Gel Pack

GUDID 00810104130738

Gel Nipple Pads (900-00135)

Exploramed NC7, Inc.

Nipple pad/ring, single-use
Primary Device ID00810104130738
NIH Device Record Keyb0bc3a7d-9349-421e-88dd-99ea40d16fd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameGel Pack
Version Model NumberGP2312
Company DUNS050917861
Company NameExploramed NC7, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810104130738 [Primary]

FDA Product Code

NTCNursing Pad, Hydrogel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-03-22
Device Publish Date2024-02-14

On-Brand Devices [Gel Pack]

00081010413073Gel Nipple Pads (900-00135)
00810104130738Gel Nipple Pads (900-00135)

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