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Gentell

FDA UDI

Class U (US FDA UDI)

by Gentell

Identity

Trade Name
Gentell FDA UDI
Generic Name
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
Device Name
GEN13044 Gelling Fiber Ag Dressing 4”x4” (10cmx10cm) FDA UDI
Model / Reference
GEN-13044 FDA UDI
Description
GEN13044 Gelling Fiber Ag Dressing 4”x4” (10cmx10cm) FDA UDI

Identifiers

Primary DI / UDI-DI
00361554007243 FDA UDI
510(k) Number
K240485 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Exudate-absorbent dressing, hydrophilic-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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

Gentell by Gentell — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K240485 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gentell

Sources (1)

  • FDA UDI 2ec7e420-92fe-434c-968d-6379993ae180 34 fields · synced Jun 8, 2026