FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 Fibe 176100arce

GUDID 10810128461334

FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 FiberWire® Suture

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 10810128461334
• NIH Device Record Key: 983ed3af-a0a1-4ca0-852d-70b071be97fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 Fibe
• Version Model Number: AR-4580SCE
• Catalog Number: 176100arce
• 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: MR Safe
• 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	10810128461334 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-25

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

• 10810128461075 - AC Slider Needle: 2025-06-05
• 10810128461150 - Champion®+ Slider Handle, Disposable: 2025-06-05
• 10810128461174 - 25° Right, Champion®+ Slider with Nitinol Passing Wire: 2025-06-05
• 10810128461181 - 25° Left, Champion®+ Slider with Nitinol Passing Wire: 2025-06-05
• 10810128461198 - 45° Right, Champion®+ Slider with Nitinol Passing Wire: 2025-06-05
• 10810128461204 - 45° Left, Champion®+ Slider with Nitinol Passing Wire: 2025-06-05
• 10810128461211 - 90° Tight Curve, Champion®+ Slider with Nitinol Passing Wire: 2025-06-05
• 10810128461228 - Crescent, Champion®+ Slider with Nitinol Passing Wire: 2025-06-05