DynaSafety XeroBurn Sterile Burn Dressing, 2" x 6"

GUDID 00840117334694

STERILE-E

DYNAREX CORPORATION

Synthetic polymer burn dressing, gel-coated
Primary Device ID00840117334694
NIH Device Record Key72072b79-8cb1-40b7-9382-437377287493
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaSafety XeroBurn Sterile Burn Dressing, 2" x 6"
Version Model Number1297
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117332928 [Package]
Contains: 00840117332935
Package: Case [16 Units]
In Commercial Distribution
GS100840117332935 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS100840117334694 [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 Date2024-03-19
Device Publish Date2024-03-11

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