Catalyst Tuberosity Repair Kit 1232-7400-001

GUDID 00810129094398

Catalyst Tuberosity Repair Kit

Threadstone LLC

Polyolefin/fluoropolymer suture, multifilament

• Primary Device ID: 00810129094398
• NIH Device Record Key: e1b70bd9-fc2d-4fc4-9a0f-e8c1ba65ff0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catalyst Tuberosity Repair Kit
• Version Model Number: 1232-7400-001
• Catalog Number: 1232-7400-001
• Company DUNS: 104319989
• Company Name: Threadstone LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00810129094398 [Primary]

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2025-12-08
• Device Publish Date: 2025-11-30

Devices Manufactured by Threadstone LLC

• 00810129092271 - HyperSuture: 2025-12-17 1.5mm White/Blue UHMWPE Surgical Suture Tape Loop, 2" Loop
• 00810129092288 - HyperSuture: 2025-12-17 1.5mm White/Black Polyblend Surgical Suture Tape Loop, 2" Loop
• 00810129094336 - Catalyst Tuberosity Repair Kit Suture Loop: 2025-12-08 2mm White UHMWPE Suture Tape Loop, 24"
• 00810129094343 - Catalyst Tuberosity Repair Kit Suture Loop: 2025-12-08 2mm White/Black Polyblend Suture Tape Loop, 24"
• 00810129094350 - Catalyst Tuberosity Repair Kit Suture Loop: 2025-12-08 2mm Blue/White UHMWPE Suture Tape Loop, 24"
• 00810129094367 - Catalyst Tuberosity Repair Kit Suture Loop: 2025-12-08 2mm Blue UHMWPE Suture Tape Loop, 24"
• 00810129094374 - Catalyst Tuberosity Repair Kit Suture Cable: 2025-12-08 USP #2 White UHMWPE Suture Cable, 36"
• 00810129094381 - Catalyst Tuberosity Repair Kit Suture Cable: 2025-12-08 USP #2 Blue UHMWPE Suture Cable, 36"