FIXIT EPA9000003

GUDID 03760154003391

Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the FIXIT implant for rotator cuff repair (1st row) with automatic grasper.

S.B.M

Arthroscopic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03760154003391
• NIH Device Record Key: 15d5fc6c-2fb8-45d1-bb91-99e30e08cb91
• Commercial Distribution Discontinuation: 2024-06-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FIXIT
• Version Model Number: Complete FIXIT basket 1st row with automatic grasp
• Catalog Number: EPA9000003
• Company DUNS: 772462123
• Company Name: S.B.M
• 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: false
• Manufacturing Date: true
• 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	03760154003391 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

[03760154003391]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-20
• Device Publish Date: 2024-06-12

On-Brand Devices [FIXIT]

• 03760154008921: Knotless threaded anchor for single interference in rotator cuff repair - Ø 6.5 mm, Length 14 m
• 03760154008914: Knotless threaded anchor for single interference in rotator cuff repair - Ø 5.5 mm, Length 14 m
• 03760154008907: Knotless threaded anchor for single interference in rotator cuff repair - Ø 4.5 mm, Length 11.2
• 03760154008884: Threaded anchor system for rotator cuff repair - CLASSIC - Ø 6.5 mm
• 03760154008860: Threaded anchor system for rotator cuff repair - CLASSIC - Ø 5.5 mm
• 03760154008846: Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.7 mm
• 03760154008853: FIXIT Ø 5.5 mm threaded anchor mounted on screwdriver
• 03760304681004: FIXIT® Band Ø 6.5 mm threaded anchor mounted on screwdriver
• 03760304680991: FIXIT® Band Ø 5.5 mm threaded anchor mounted on screwdriver
• 03760304680984: FIXIT® Band Ø 4.5 mm threaded anchor mounted on screwdriver
• 03760154003353: Reusable suture retriever pin, to be used with FIXIT suture anchors for rotator cuff repair.
• 03760154003520: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760154003513: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760154003391: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760154003384: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a