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Microlyte AG

FDA UDI

Class U (US FDA UDI)

by Imbed Biosciences, Inc.

Identity

Trade Name
Microlyte AG FDA UDI
Generic Name
Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial FDA UDI
Device Name
Gelling fiber wound dressing, 2" x 2" FDA UDI
Model / Reference
91001 FDA UDI
Description
Gelling fiber wound dressing, 2" x 2" FDA UDI

Identifiers

Catalog Number
91001 FDA UDI
Primary DI / UDI-DI
B519910010 FDA UDI
510(k) Number
K153756 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not 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

Yes

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

Dimensions & Sizes

Size
Area/Surface Area — 4 Square inch FDA UDI

Microlyte AG by Imbed Biosciences, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153756 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imbed Biosciences, Inc.

Sources (1)

  • FDA UDI b427d3e3-153c-44b4-b4f7-9025833265ce 39 fields · synced May 30, 2026