XeroBurn Burn Dressing Face Mask- Sterile

GUDID 00840117333079

12" x 16"

DYNAREX CORPORATION

Synthetic polymer burn dressing, gel-coated
Primary Device ID00840117333079
NIH Device Record Key1cd9c54e-5cf7-4101-959e-1fdb944058b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameXeroBurn Burn Dressing Face Mask- Sterile
Version Model Number1371
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117333062 [Package]
Package: MC Master [2 Units]
In Commercial Distribution
GS100840117333079 [Package]
Contains: 00840117333277
Package: BOX [6 Units]
In Commercial Distribution
GS100840117333277 [Primary]

FDA Product Code

NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

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