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Biatain Silicone Ag

FDA UDI

Class U (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Biatain Silicone Ag FDA UDI
Generic Name
Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
Model / Reference
39645 FDA UDI

Identifiers

Catalog Number
39645 FDA UDI
Primary DI / UDI-DI
05701780211413 FDA UDI
510(k) Number
K191536 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Width — 10 Centimeter FDA UDI
Length — 11.8 Inch FDA UDI
Width — 4 Inch FDA UDI
Length — 30 Centimeter FDA UDI

Category: Exudate-absorbent dressing, non-gel, antimicrobial

Biatain Silicone Ag by Coloplast A/S — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.

Cleared under the same submission

K191536 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 988a6a33-be8c-4231-92b1-99fbbadb35c4 37 fields · synced May 30, 2026