| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 10818674021798 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-10-19 |
| Device Publish Date | 2019-10-11 |
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| 10810128460603 - TruFire™ | 2024-11-06 TruFire™ Suture Passer Needle |
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| 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 |