WEGO-PGLA Absorbable Surgical Suture With Needle

GUDID 06941813626695

Foosin Medical Supplies Inc., Ltd.

Polyglycolic acid suture
Primary Device ID06941813626695
NIH Device Record Key26fd74a7-c145-48a6-9783-6379e671dfa5
Commercial Distribution StatusIn Commercial Distribution
Brand NameWEGO-PGLA Absorbable Surgical Suture With Needle
Version Model NumberAB4040
Company DUNS528180159
Company NameFoosin Medical Supplies Inc., Ltd.
Device Count1
DM Exempttrue
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
GS106941813621690 [Primary]
GS106941813626695 [Package]
Contains: 06941813621690
Package: [12 Units]
In Commercial Distribution

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-04-14

On-Brand Devices [WEGO-PGLA Absorbable Surgical Suture With Needle]

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06941813626329A58113UD
06941813626312A58084D
06941813626305A53163
06941813626299A53193

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