Xeroform Petrolatum Dressings

GUDID 00840117324244

3% Bismuth Tribromophenate in a petrolatum blend Med-High Absorbency For wound stages 2,3,4

DYNAREX CORPORATION

Wound hydrogel dressing, non-antimicrobial
Primary Device ID00840117324244
NIH Device Record Keyef85b13d-74d0-442e-82d2-7604f75709c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameXeroform Petrolatum Dressings
Version Model Number3042
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117324237 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS100840117324244 [Primary]
GS100840117324251 [Package]
Contains: 00840117324237
Package: Case [6 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 Date2022-09-14
Device Publish Date2022-09-06

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