MISTER Tendon Harvester P68-101-0000-SK

GUDID 00889795128751

Tendon Harvester & Dilator Sterile Kit

PARAGON 28, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00889795128751
• NIH Device Record Key: 3cd7c95e-9aba-4099-a516-f68690d56d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MISTER Tendon Harvester
• Version Model Number: P68-101-0000-SK
• Catalog Number: P68-101-0000-SK
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00889795128751 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

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: 2024-01-24
• Device Publish Date: 2024-01-16

Devices Manufactured by PARAGON 28, INC.

• 00889795099662 - Baby Gorilla® / Gorilla® Plating System: 2025-04-25 Gorilla®, R3CON™ Screw, Ø2.7 x 56mm, Non-Locking, Solid, TiA
• 00889795099679 - Baby Gorilla® / Gorilla® Plating System: 2025-04-25 Gorilla®, R3CON™ Screw, Ø2.7 x 58mm, Non-Locking, Solid, TiA
• 00889795099686 - Baby Gorilla® / Gorilla® Plating System: 2025-04-25 Gorilla®, R3CON™ Screw, Ø2.7 x 60mm, Non-Locking, Solid, TiA
• 00889795141439 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Targeting Guide Assembly
• 00889795141446 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Talar Carriage Assembly
• 00889795141460 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Sustentaculum Wire Guide
• 00889795141477 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Talar Wire Guide
• 00889795141491 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Sinus Tarsai Dilator