WEGO-PGLA Absorbable Surgical Suture With Needle

GUDID 06941813626343

Foosin Medical Supplies Inc., Ltd.

Polyglycolic acid suture
Primary Device ID06941813626343
NIH Device Record Key7b93d47e-a6ec-4ed3-af37-851af84d7081
Commercial Distribution StatusIn Commercial Distribution
Brand NameWEGO-PGLA Absorbable Surgical Suture With Needle
Version Model NumberA61132U
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
GS106941813621348 [Primary]
GS106941813626343 [Package]
Contains: 06941813621348
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 Date2016-04-13

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

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06941813626770AC3402
06941813626763AC1482
06941813626756AC1452
06941813626749AC1402
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06941813626701AB7402
06941813626695AB4040
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06941813626671AB3482
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06941813626626AB3303
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06941813626572AB1482
06941813626565AB1452
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06941813626527AB1312
06941813626510AB1302
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06941813626442A88063D
06941813626435A78082D
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06941813626411A68133UD
06941813626404A68084D
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06941813626381A63103
06941813626374A61172
06941813626362A61163
06941813626350A61152
06941813626343A61132U
06941813626336A61132
06941813626329A58113UD
06941813626312A58084D
06941813626305A53163
06941813626299A53193

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