ecoFIX EPA9000007

GUDID 03760304681271

Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the ecoFIX implant for rotator cuff repair (1st and 2nd rows).

S.B.M

Arthroscopic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03760304681271
• NIH Device Record Key: 25a93c3f-805f-4552-be1d-06379100f77a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ecoFIX
• Version Model Number: Complete ecoFIX basket - 1st and 2nd rows
• Catalog Number: EPA9000007
• 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	03760304681271 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

[03760304681271]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-20
• Device Publish Date: 2024-06-12

On-Brand Devices [ecoFIX]

• 03760304680595: Ø 4.5 mm anchor mounted on reel with 2 round sutures
• 03760304680618: Ø 6.5 mm anchor mounted on reel with 2 round sutures
• 03760304680601: Ø 5.5 mm anchor mounted on reel with 2 round sutures
• 03760304681127: Screwdriver to be used with diameter 5.5 mm and 6.5 mm ecoFIX anchors for rotator cuff repair.
• 03760304681110: Screwdriver to be used with diameter 4.5 mm ecoFIX anchors for rotator cuff repair.
• 03760304681288: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760304681271: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760304681264: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760304681257: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a