Durma+ DynaGinate AG, Calcium Alginate Dressing, 4" x 4"

GUDID 00840117343689

Dynarex Corporation

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID00840117343689
NIH Device Record Keyabad4c90-6799-431a-bfd4-b3027d519716
Commercial Distribution StatusIn Commercial Distribution
Brand NameDurma+ DynaGinate AG, Calcium Alginate Dressing, 4" x 4"
Version Model Number3010
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117343689 [Primary]
GS100840117343696 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS100840117343702 [Package]
Contains: 00840117343696
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-06
Device Publish Date2025-05-29

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