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 Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable 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

• 03760154002486 - LIGAFIX: 2023-12-29 Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X5 to be used with LIGAFIX interference screws for ACL reconstruction.
• 03760154002493 - LIGAFIX: 2023-12-29 Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X10 to be used with LIGAFIX interference screws for ACL reconstruction.
• 03760154002561 - LIGAFIX: 2023-12-29 Rigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X5, for ACL reconstruction.
• 03760154002578 - LIGAFIX: 2023-12-29 Rigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X10, for ACL reconstruction.
• 03760154002608 - LIGAFIX: 2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X5, for ACL reconstruction.
• 03760154002615 - LIGAFIX: 2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X10, for ACL reconstruction.
• 03760154002622 - LIGAFIX: 2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X1, for ACL reconstruction.
• 03760154002639 - LIGAFIX: 2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X5, for ACL reconstruction.