Xeroform Petrolatum Dressings, 4"x4"

GUDID 00616784305318

3% Bismuth Tribromophenate in a petrolatum blend, Sterile

DYNAREX CORPORATION

Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial
Primary Device ID00616784305318
NIH Device Record Key7aa247f2-6d78-494f-85b9-dee3bf0c4db6
Commercial Distribution StatusIn Commercial Distribution
Brand NameXeroform Petrolatum Dressings, 4"x4"
Version Model Number3053
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 Datetrue
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
GS100616784305318 [Primary]
GS100616784305325 [Package]
Package: Box [25 Units]
In Commercial Distribution
GS100616784305332 [Package]
Contains: 00616784305325
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-11
Device Publish Date2022-10-03

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