Primary Device ID | 00854288008407 |
NIH Device Record Key | 7526bf48-50a0-4c1b-bfc8-90fdfdebd5bb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tigon Medical |
Version Model Number | LIGO-10 |
Catalog Number | LIGO-10 |
Company DUNS | 080929031 |
Company Name | Tigon Medical LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Manufacturing Date | false |
Expiration Date | false |
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 | 00854288008407 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
[00854288008407]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-14 |
Device Publish Date | 2023-06-06 |
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 |