Manufacturing Certifications

Manufacturing Certifications
-
FDA Registered
FDA 510(k) Premarket Notification
ISO13485 Quality System – Certificate
CE Mark
Certified ISO Class 8 Clean Rooms
CPP (Critical Product Production) Room
ISO 10993 Biocompatible
ISO 11135 Sterilization Validation
16CFR1610:2007 – Compliant Flammability Rated
Product Groups:
1.
2.
3.
4.
5.
Microscope Drapes
C-Arm Drapes
Camera Drapes
Probe Covers
Miscellaneous
- Scope Warmers
- Back Table Covers
- Surgical Gowns
6.
Face Shields
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1. Microscope Drapes
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1. Wide range of Microscope drapes to fit specific microscope
needs.
2. The Microscope drapes are made from high quality (PE)
polyethylene film impregnated with a special anti-blocking
formula that allows easy draping without film sticking.
3. Straps to secure the drape allow a quick and easy draping.
4. All the drapes come with an angled lens to prevent glare
during the procedure.
5. The lens covers used are made of high grade material that
delivers sharp optical quality and clear visibility.
2. C-Arm Drapes and C-Arm kits
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The C-Arm kit uses an organizer sleeve in
packaging. End-user can easily locate the right part.
2. C-Arm Drapes and C-Arm kits
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C-Sheet to preserve sterility when arm moves from non-sterile to sterile field.
E5923
rotation
E5927
Rotation and Axial Rotation
2. C-Arm Drapes and C-Arm kits
O-Shape drape
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E6100
E6101
3. Camera Drapes
A surgical video camera is used during endoscopic
applications for example in laparoscopic
or arthroscopic procedures.
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Camera with cable
Scope
processor
Only part draped is the camera and cable.
The Scope is cleaned and disinfected.
In a Laparoscopic procedure use of Scope Warmer is recommended
3. Camera Drapes
Key in choice of camera drapes:
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 Width of the tube film
 Length of the tube film
 Insert assistance, optional with Cardboard, or Ring
 Use of elastic bands and tape
 Tip of the camera Drape:
 Open
 Closed (tear-off)
 Elastic White or Blue Kraton
 Coupler system (allows change of Scope without re-draping)
3. Camera Drapes
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Camera Drape with Cardboard insert assistance
Camera Drape with ring insert assistance design
insert assistance.
3. Camera Drapes
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White Elastic Tip
Blue Elastic Tip
Perforated Tip
Open Tip
3. Camera Drapes
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23cm – 9"
Closed Camera Drape system.
Change scope without re-draping
244cm - 96"
4. Probe Covers
Material Options offers options in material used:
• Polyethylene (PE)
Commonly used basic material
• Thermoplastic elastomer (TPE)
When customer wants to have a softer material
Box Tip Construction:
The tip should not have a seam that
interferes with the ultrasonic image
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4. Probe Covers
High Grade Ultrasonic Gel
Purpose is to use inside the probe cover and enhances
the Ultrasound image quality.
Can however also be used outside the probe cover
and even intra-operative.
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®
®
Sterile
GEL
Red indicates sterilization
REF
EXXXX
LOT
XXXXXX
XX-20XX
35° C / 98° F
10° C / 50° F
Contact medium for Ultrasonic and
Electrical Transmission Gel
20 ML
Exact Medical Manufacturing
www.exactmm.com
[email protected]
STERILE R
2
!
Unit Pouch is guaranteed sterile
unless opened or damaged
1014
Ingredients: Deionized water, Carbomer,
Triethanolamine, Monopropylene Glycol, 5chloro-2-methyl-4-isothiazolin-3-one, 2methyl-4-isothiazolin-3-one
Instructions: Open sachet on top side,
Apply some Gel to application area. After
application dispose of the sachet to prevent
re-application.
Purpose of use: Improve conductivity
during Ultrasound Diagnostics
Warnings
 Keep away from children



Keep product at room temperature
The product is for single use
Products used by professional users
Distributed by:
Exact Medical Manufacturing Inc.
4917 William Street
Lancaster, NY, 14086
United States of America
EC
REP
Exact Medical Manufacturing BV
Kerkstraat 35
5253 AN Nieuwkuijk
The Netherlands
( +31 73 760 06 75
4. Probe Covers
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Probe Covers can have tape for a tight fit and latex free
rubber bands.
No Gel needed, probe can be fixed with tape.
This tape is easy to remove and guarantees
a clear ultrasonic image.
5. Miscellaneous
Scope Warmers Features
• It takes Two minutes after the strike of metal
for thermal bag to become solid. Liquid
temperature, of the warmer is at least 104
Degrees Fahrenheit.
• It takes under two minutes to warm the scope.
• The warmer will not return to room temperature
in less than 1 hr.
• The Scope warmer can be used with the DaVinci.
• No Batteries are needed.
• The scope Warmer is a disposable Product.
• Latex and DEHP Free.
• Packaged Sterile
The Scope Warmer can also
safely accommodate daVinci optics
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5. Miscellaneous
E6001 / E6001FF
Back Table Covers
44"
75"
PE
Reinforcement
Cross References
Product Number
Description
Size (W x L)
E6001FF
Back Table Cover
44" x 75"
(24" x 75")
Cardinal
Kimberly Clark
Medline
A8376N
79445 / 79448
DYNJP2309
E6001FF Features
~ Fan Folded
~ Absorbent Reinforcement 24" x 75"
5. Miscellaneous
Surgical Gowns – Fabric Reinforced Gown
AAMI Level
Sleeve Types:
1
2
3
4
Set-In / Raglan (by
special request)
~
~~
~
Features
~ adjustable velcro & pile on
gown neck
~ fabric reinforced
Use
~ for medium fluid level
procedures
Regular SMS /
Soft SMS
Fabric
Reinforcement
Poly
Reinforcement
Cross References
Product Number
Description
Size (W x L)
EP0221
Fabric Reinforced SMS Gown
EP0231
Fabric Reinforced SMS Gown
Cardinal
Kimberly Clark
Medline
L
9511N
78911 / 78917 /90112
DYNJP2101S /
SPT2101SMS
XL
9541N
78921 / 78927 / 90142
DYNJP2102S /
SPT2102SMS
5. Miscellaneous
Surgical Gowns – AAMI 4 Gown
AAMI Level
Sleeve Types:
1
2
3
4
Set-In / Raglan (by
special request)
Features
~ adjustable velcro & pile on
gown neck
~
~~
~
~ breathable material
Use
~ for heavier fluid level
procedures
AAMI 4 Breathable Material
Cross References
Product Number
Description
Size (W x L)
E40121
AAMI 4 Gown
E40131
AAMI 4 Gown
Cardinal
Kimberly Clark
Medline
L
9011 / 9011N
72438
DYNJP2306P
XL
9041 / 9041N
72445
DYNJP2307P
6. Face Shields
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Standard Shield
(Model 16000)
9 x 13 inch full face
protection
Drape Shield (Model 18000)
Short (7 inch) fluid barrier fabric
below Standard Shield
Fabric stays outside of protective
garments. Can cup under chin.
Drape Wide Shield
(Model 18000W)
6. Face Shields
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7. Miscellaneous
Scope Warmer
- Sterile packed and disposable
- Easily activated
- Can be used to warm two endoscopes at a time
- Scope stays warm for 45 minutes to one hour
- Easy to use different size scopes.
- No alcohol
- No need for costly decontamination, sterilization,
and additional sterile water for Thermos-type warmers
- Disposable & environmentally friendly
- Sterile
- Latex and DEHP free
- CE marked
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Onyx Medical Inc.
16 Digital Drive, Suite 120
Novato, CA 94949
Toll-Free:
800-333-5773
Phone
415-884-4412
EMAIL US at
[email protected]