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Gel Pack

FDA UDI

Class I (US FDA UDI)

by Willow Innovations, Inc.

Identity

Trade Name
Gel Pack FDA UDI
Generic Name
Nipple pad/ring, single-use FDA UDI
Device Name
Gel Nipple Pads (900-00135) FDA UDI
Model / Reference
GP2312 FDA UDI
Description
Gel Nipple Pads (900-00135) FDA UDI

Identifiers

Primary DI / UDI-DI
00810104130738 FDA UDI
FDA Product Code
NTC FDA UDI
GMDN Term
Nipple pad/ring, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nipple pad/ring, single-use

Gel Pack by Willow Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nipple pad/ring, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Willow Innovations, Inc.

Sources (1)

  • FDA UDI b0bc3a7d-9349-421e-88dd-99ea40d16fd3 33 fields · synced May 30, 2026