WARMGEL INSTANT HEAT PACK - Large

GUDID 20888937025730

WARMGEL INSTANT HEAT PACK - Large

Coopersurgical, Inc.

Reactive-gel heating pad
Primary Device ID20888937025730
NIH Device Record Key567c6f1b-13c6-4ca2-814c-f0009e3d2237
Commercial Distribution StatusIn Commercial Distribution
Brand NameWARMGEL INSTANT HEAT PACK - Large
Version Model Number20420
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS120888937025730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IMDPack, Hot Or Cold, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-07
Device Publish Date2022-11-29

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