Humelock II

GUDID 03701037320532

HUMELOCK II TRAY

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037320532
• NIH Device Record Key: d5e70cdb-7fb5-44ee-8a81-f49122488b18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humelock II
• Version Model Number: 603-0017
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• 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: false
• 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	03701037320532 [Primary]

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

[03701037320532]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-11
• Device Publish Date: 2025-03-03

Devices Manufactured by FX SOLUTIONS

• 03701037318669 - FX V135 Shoulder Prosthesis: 2025-04-17 BROACH Ø32/10 LG 120MM FX V135
• 03701037318676 - FX V135 Shoulder Prosthesis: 2025-04-17 BROACH Ø32/12 LG 120MM FX V135
• 03701037318683 - FX V135 Shoulder Prosthesis: 2025-04-17 BROACH Ø36/10 LG 120MM FX V135
• 03701037318690 - FX V135 Shoulder Prosthesis: 2025-04-17 BROACH Ø36/12 LG 120MM FX V135
• 03701037318706 - FX V135 Shoulder Prosthesis: 2025-04-17 BROACH Ø36/14 LG 120MM FX V135
• 03701037318713 - FX V135 Shoulder Prosthesis: 2025-04-17 BROACH Ø40/12 LG 120MM FX V135
• 03701037318737 - FX V135 Shoulder Prosthesis: 2025-04-17 BROACH Ø40/16 LG 120MM FX V135
• 03701037318652 - FX V135 Shoulder Prosthesis: 2025-04-15 BROACH Ø32/08 LG 120MM FX V135