MedSource Burn Sheet Not Applicable

GUDID 00816703023563

Burn Sheet

MEDSOURCE INTERNATIONAL LLC

Cotton burn sheet
Primary Device ID00816703023563
NIH Device Record Key72f5c21e-c26a-4f40-ae87-3cb4f54f7863
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedSource Burn Sheet
Version Model NumberNORTH-201969
Catalog NumberNot Applicable
Company DUNS041674552
Company NameMEDSOURCE INTERNATIONAL LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816703023556 [Primary]
GS100816703023563 [Package]
Contains: 00816703023556
Package: Case [50 Units]
In Commercial Distribution

FDA Product Code

NABGauze / Sponge,Nonresorbable For External Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-25
Device Publish Date2021-08-17

On-Brand Devices [MedSource Burn Sheet]

00840155400719Burn Sheet
00840155400696Burn Sheet
00816703023563Burn Sheet

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