| Primary Device ID | 00867430000426 |
| NIH Device Record Key | f4b4a9cd-958e-408d-9cba-4dd2c7682350 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tigon Medical |
| Version Model Number | TIG48-TIGLASSO |
| Catalog Number | TIG48-TIGLASSO |
| Company DUNS | 080929031 |
| Company Name | Tigon Medical LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867430000426 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-07 |
| Device Publish Date | 2020-09-29 |
| 00867430000495 | Suture Lasso |
| 00867430000457 | 5.5 Medial Anchor |
| 00867430000426 | 4.8 Lateral Anchor Knotless |
| 00854288008353 | Cannulated Quick Connect |
| 00854288008254 | Blunt Medial Anchor Shaft |
| 00854288008247 | Tapered Awl |
| 00854288008230 | 2.6mm Drill |
| 00854288008223 | 5.5mm Medial Tap |
| 00854288008216 | Needle for Passer (disposable) |
| 00854288008209 | Suture Passer |
| 00854288008193 | 2.3 Drill |
| 00854288008186 | 2.9 Cannula |
| 00854288008179 | Awl |
| 00854288008162 | Threaded Blocker for Lateral Handle |
| 00854288008155 | Lateral Knotless Handle Cannulated |
| 00854288008148 | Shaft for Medial Anchor with Spike |
| 00854288008131 | Shaft for Knotless Labral Anchor Threaded |
| 00854288008124 | Quick Connect Handle |
| 00854288008117 | Shaft for Labral Anchor |
| 00854288008100 | Shoulder Instrument Tray |
| 00854288008094 | Double Suture Lasso for Anchors |
| 00854288008087 | 2.9 Labral Anchor/No Lasso |
| 00854288008063 | 2.9 Knotless Labral Anchor |
| 00854288008025 | 5.5 Medial Anchor with 2 - #2 sliding sutures |
| 00867430000471 | 6.5 Medial Anchor - Manticore |
| 00867430000440 | 6.0 Lateral Anchor Knotless - Manticore with Suture Lasso |
| 00867430000402 | 2.9 Labral Anchor - Manticore with Double Suture Lasso |
| 00854288008926 | Button Outer Shaft |
| 00854288008919 | Inner Inserter Button Assembly |
| 00854288008810 | Button Caddy |
| 00854288008766 | Foot and Ankle Tray |
| 00854288008735 | Tigon Button 2.6x8mm |
| 00854288008452 | 3.8m drill |
| 00854288008445 | Blunt Screw in Anchor Inserter |
| 00854288008438 | 2.6mm Drill for Hard Bone |
| 00854288008414 | 5.5mm Tap for Foot and Ankle |
| 00854288008407 | 2.3mm Drill for Foot and Ankle |
| 00854288008391 | Foot and Ankle Drill Guide |
| 00854288008384 | 4.8mm Anchor Inner Inserter |
| 00854288008377 | Outer 4.8mm Anchor Inserter |
| 00854288008360 | 2.9mm Anchor Inserter for Foot and Ankle |
| 00850029805793 | Foot and Ankle Obturator |
| 00850029805656 | Vented Knotless Anchor (8.75 mm x 2.9 mm) with Suture Lasso |
| 00850029805373 | Vented Tying Anchor (8.75 mm x 2.9 mm) no Lasso |
| 00850029805328 | Round Quick Connect Handle |
| 00850029805304 | Small Dual Outer Inserter |
| 00850029805298 | 15 mm Dual Inner Shaft |
| 00850029805281 | 10 mm Dual Inner Shaft |
| 00850029805274 | 6 mm Dual Inner Shaft |
| 00850029805267 | Nitinol Passing Wire |