Tigon Medical TM-GALT001

GUDID 00850029805946

Inner Inserter Dual Anchor

Tigon Medical LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00850029805946
• NIH Device Record Key: 2226c97b-8486-408d-89b1-c1686a43b8e1
• Commercial Distribution Discontinuation: 2023-09-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tigon Medical
• Version Model Number: TM-GALT001
• Catalog Number: TM-GALT001
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850029805946 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

[00850029805946]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [Tigon Medical]

• 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