WEGO-PGLA Absorbable Surgical Suture With Needle

GUDID 06941813626794

Foosin Medical Supplies Inc., Ltd.

Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial

• Primary Device ID: 06941813626794
• NIH Device Record Key: 44c3e3af-12a6-48db-b4fd-1c2fabca1f3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WEGO-PGLA Absorbable Surgical Suture With Needle
• Version Model Number: A4-45 x 6
• Company DUNS: 528180159
• Company Name: Foosin Medical Supplies Inc., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06941813621799 [Primary]
GS1	06941813626794 [Package]; Contains: 06941813621799; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130735

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-02
• Device Publish Date: 2020-08-25

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

• 06941813626787: AC3482
• 06941813626770: AC3402
• 06941813626763: AC1482
• 06941813626756: AC1452
• 06941813626749: AC1402
• 06941813626732: AC015001
• 06941813626725: AC004512
• 06941813626718: AC004506
• 06941813626701: AB7402
• 06941813626695: AB4040
• 06941813626688: AB3482H
• 06941813626671: AB3482
• 06941813626664: AB3403
• 06941813626657: AB3402
• 06941813626640: AB3363
• 06941813626633: AB3362
• 06941813626626: AB3303
• 06941813626619: AB3302
• 06941813626602: AB2643
• 06941813626596: AB1502
• 06941813626589: AB1482H
• 06941813626572: AB1482
• 06941813626565: AB1452
• 06941813626558: AB1402
• 06941813626541: AB1372
• 06941813626534: AB1362
• 06941813626527: AB1312
• 06941813626510: AB1302
• 06941813626503: AB018001
• 06941813626497: AB015001
• 06941813626480: AB007002
• 06941813626473: AB004512
• 06941813626466: AB004506
• 06941813626459: AB004503
• 06941813626442: A88063D
• 06941813626435: A78082D
• 06941813626428: A78063D
• 06941813626411: A68133UD
• 06941813626404: A68084D
• 06941813626398: A63123
• 06941813626381: A63103
• 06941813626374: A61172
• 06941813626362: A61163
• 06941813626350: A61152
• 06941813626343: A61132U
• 06941813626336: A61132
• 06941813626329: A58113UD
• 06941813626312: A58084D
• 06941813626305: A53163
• 06941813626299: A53193