FIXIT EPA9000303

GUDID 03760154003353

Reusable suture retriever pin, to be used with FIXIT suture anchors for rotator cuff repair.

S.B.M

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• Primary Device ID: 03760154003353
• NIH Device Record Key: 02148413-c312-43a6-b13e-b2d40f6f325b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIXIT
• Version Model Number: Reusable suture retriever pin
• Catalog Number: EPA9000303
• 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	03760154003353 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

[03760154003353]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-29
• Device Publish Date: 2023-12-21

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.