FIXIT Knotless & ecoFIX Knotless EPA9000315

GUDID 03760154009751

Screwdriver to be used with FIXIT Knotless and ecoFIX Knotless anchors for rotator cuff repair.

S.B.M

Surgical screwdriver, reusable

• Primary Device ID: 03760154009751
• NIH Device Record Key: bb9e576d-aefb-4c3e-bdfd-200625471a0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIXIT Knotless & ecoFIX Knotless
• Version Model Number: Screwdriver
• Catalog Number: EPA9000315
• 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	03760154009751 [Primary]

FDA Product Code

• HXX: Screwdriver

Sterilization

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

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

Moist Heat or Steam Sterilization

[03760154009751]

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

Devices Manufactured by S.B.M

• 03760304681332 - FIXIT / ecoFIX: 2024-09-26 Punch used with a FIXIT or ecoFIX implant for rotator cuff repair.
• 03760304681080 - SBM: 2024-07-03 Complete instrumentation tray composed of reusable surgical instruments for extremity surgery.
• 03760304681318 - SBM: 2024-07-03 250 x 250 sterilization basket lid
• 03760304681325 - SBM: 2024-07-03 250 x 250 sterilization basket with silicone mat
• 03760154001069 - OTIS-C-PLUS: 2024-06-28 Depth gauge for HTO.
• 03760154005685 - LIGAFIX: 2024-06-28 Chondral pick for ACL reconstruction.
• 03760154008167 - OTIS-F: 2024-06-28 Handle for the OTIS-F AO drill guide
• 03760154008174 - OTIS-F: 2024-06-28 AO drill guide