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Ameda, Inc.

FDA UDI

Class U (US FDA UDI)

by Ameda, Inc.

Identity

Trade Name
Ameda, Inc. FDA UDI
Generic Name
Wound hydrogel dressing, non-antimicrobial FDA UDI
Device Name
ComfortGel HydroGel Pads (STL) FDA UDI
Model / Reference
17261M FDA UDI
Description
ComfortGel HydroGel Pads (STL) FDA UDI

Identifiers

Catalog Number
17261M FDA UDI
Primary DI / UDI-DI
00810725020166 FDA UDI
FDA Product Code
MGQ FDA UDI
GMDN Term
Wound hydrogel dressing, non-antimicrobial FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wound hydrogel dressing, non-antimicrobial

Ameda, Inc. by Ameda, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound hydrogel dressing, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ameda, Inc.

Sources (1)

  • FDA UDI 1b8cbbf9-1a69-4acd-9c5a-0c45830d371e 35 fields · synced Jun 8, 2026