FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® Sutu 171000ar

GUDID 10818674021798

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 10818674021798
• NIH Device Record Key: 63612b7f-c25f-4bcb-bbdb-ce057c7dd18a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® Sutu
• Version Model Number: AR-4570
• Catalog Number: 171000ar
• Company DUNS: 534123013
• Company Name: T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
• Device Count: 1
• DM Exempt: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818674021798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190125

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-10-19
• Device Publish Date: 2019-10-11

Devices Manufactured by T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

• 10810128460610 - TruFire™: 2024-11-06 TruFire™ Suture Passer with Non-Ratcheting Handle
• 10810128460627 - TruFire™: 2024-11-06 TruFire™ Suture Passer with Ratcheting Handle
• 10810128460603 - TruFire™: 2024-11-06 TruFire™ Suture Passer Needle
• 10810128461006 - HydroSeal™: 2024-10-07 HydroSeal™ Silicone Cannula 8mm x 20mm
• 10810128461013 - HydroSeal™: 2024-10-07 HydroSeal™ Silicone Cannula 8mm x 30mm
• 10810128461020 - HydroSeal™: 2024-10-07 HydroSeal™ Silicone Cannula 8mm x 50mm
• 10810128461037 - HydroSeal™: 2024-10-07 HydroSeal™ Silicone Cannula 12mm x 40mm
• 10810128461044 - HydroSeal™: 2024-10-07 HydroSeal™ Silicone Cannula 10mm x 30mm