DEVICE: Biatain Silicone .pdf) (05701780261654)

Device Identifier (DI) Information

Biatain Silicone .pdf)
33437
In Commercial Distribution
33437
Coloplast A/S
05701780261654
GS1

1
305524696 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44970 Exudate-absorbent dressing, non-gel, non-antimicrobial
A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NAD Dressing, wound, occlusive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not use if package is damaged and consult IFU.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Pad Width - in 4.1
Device Size Text, specify: Pad Length - in 4.1
Device Size Text, specify: Pad Width - cm 10.5
Length: 15 Centimeter
Device Size Text, specify: Dressing Shape Square
Device Size Text, specify: Pad Length - cm 10.5
Width: 6 Inch
Length: 6 Inch
Width: 15 Centimeter
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Device Record Status

01b997c2-5934-41d1-991f-df39fd7becec
December 13, 2022
1
December 05, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05708932576109 24 05708932576093 In Commercial Distribution Shipper Box
05708932576093 5 05701780261654 In Commercial Distribution Retail Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)533-0464
healthcarecs@coloplast.com
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