FIXIT / ecoFIX EPA9000454

GUDID 03760304681615

Suture passer automatic grasper - Shoulder

S.B.M

Suturing unit, reusable

• Primary Device ID: 03760304681615
• NIH Device Record Key: a6b9975b-f8f1-402c-abe4-818a4fdc2335
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIXIT / ecoFIX
• Version Model Number: Suture passer automatic grasper - Shoulder
• Catalog Number: EPA9000454
• 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	03760304681615 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760304681615]

Moist Heat or Steam Sterilization

[03760304681615]

Moist Heat or Steam Sterilization

[03760304681615]

Moist Heat or Steam Sterilization

[03760304681615]

Moist Heat or Steam Sterilization

[03760304681615]

Moist Heat or Steam Sterilization

[03760304681615]

Moist Heat or Steam Sterilization

[03760304681615]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-04
• Device Publish Date: 2025-06-26

On-Brand Devices [FIXIT / ecoFIX]

• 03760304681332: Punch used with a FIXIT or ecoFIX implant for rotator cuff repair.
• 03760304681615: Suture passer automatic grasper - Shoulder