PGA RESORBA

GUDID E203USPA10348

Resorba Medical GmbH

Polyglycolic acid suture
Primary Device IDE203USPA10348
NIH Device Record Keya187549e-321d-42cb-abdb-5bfa06bf3f3f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePGA RESORBA
Version Model NumberPGA RESORBA
Company DUNS341053195
Company NameResorba Medical GmbH
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE203USPA10348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-08
Device Publish Date2019-01-23

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