FIXIT & ecoFIX EPA9000247

GUDID 03760154002882

FIXIT mallet to be used with FIXIT suture anchors for rotator cuff repair.

S.B.M

Surgical mallet

• Primary Device ID: 03760154002882
• NIH Device Record Key: a2421b7e-21f2-44ba-a5a5-6970b211da02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIXIT & ecoFIX
• Version Model Number: Mallet
• Catalog Number: EPA9000247
• 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	03760154002882 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

[03760154002882]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-28
• Device Publish Date: 2023-12-20

On-Brand Devices [FIXIT & ecoFIX]

• 03760154002882: FIXIT mallet to be used with FIXIT suture anchors for rotator cuff repair.
• 03760154009744: Punch Tap to be used with diameter 5.5 mm and 6.5 mm FIXIT and ecoFIX suture anchors for rotator
• 03760154009737: Punch Tap to be used with diameter 4.5 mm FIXIT and ecoFIX suture anchors for rotator cuff repai
• 03760154003360: FIXIT® / ecoFIX® cleaning and sterilization basket.