PGA RESORBA

GUDID E203OD034009

Resorba Medical GmbH

Polyester suture, bioabsorbable, multifilament
Primary Device IDE203OD034009
NIH Device Record Key558bf83a-b695-4a3d-a913-3eccb4159d6c
Commercial Distribution Discontinuation2019-11-05
Commercial Distribution StatusNot in 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
HIBCCE203OD034009 [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 Number5
Public Version Date2019-12-10
Device Publish Date2016-09-24

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E203USPA1210PGA RESORBA
E203USPA1174PGA RESORBA
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E203USPA11523PGA RESORBA
E203USPA1152PGA RESORBA
E203USPA11519PGA RESORBA
E203USPA11517PGA RESORBA
E203USPA11510PGA RESORBA
E203USPA1151PGA RESORBA
E203USPA1150PGA RESORBA
E203USPA1146PGA RESORBA
E203USPA1145PGA RESORBA
E203USPA1143PGA RESORBA
E203USPA11425PGA RESORBA
E203USPA11424PGA RESORBA
E203USPA11416PGA RESORBA
E203USPA11413PGA RESORBA
E203USPA1141PGA RESORBA
E203USPA1140PGA RESORBA
E203USPA1119PGA RESORBA
E203USPA1116PGA RESORBA
E203USPA1111PGA RESORBA
E203USPA1110PGA RESORBA
E203USPA1065PGA RESORBA
E203USPA1056PGA RESORBA
E203USPA1048PGA RESORBA
E203USPA10386PGA RESORBA
E203USPA10385PGA RESORBA
E203USPA10384PGA RESORBA
E203USPA10383PGA RESORBA
E203USPA103829PGA RESORBA
E203USPA103819PGA RESORBA
E203USPA10371PGA RESORBA
E203USPA10370PGA RESORBA
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