FiberStitch™ Implant 1.5, Reverse Curved with two Polyester Implants and 2-0 Fib 176300ar

GUDID 10818674027110

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 10818674027110
• NIH Device Record Key: 11e50205-74b4-4e39-a01b-8514f8a8463e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FiberStitch™ Implant 1.5, Reverse Curved with two Polyester Implants and 2-0 Fib
• Version Model Number: AR-4580R
• Catalog Number: 176300ar
• 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	10818674027110 [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: 2023-10-05
• Device Publish Date: 2023-09-27

On-Brand Devices [FiberStitch™ Implant 1.5, Reverse Curved with two Polyester Implants and 2-0 Fib]

• 10818674027110: AR-4580R
• 10810128461358: FiberStitch™ Implant 1.5, Reverse Curved with two Polyester Implants and 2-0 FiberWire® Sutur