HUMELOCK REVERSED 903-3214

GUDID 03701037307854

TRIAL HUMELOCK REVERSED STEMI Ø32/14

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037307854
• NIH Device Record Key: f2762354-857c-4266-8f38-d6b3bd46f278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUMELOCK REVERSED
• Version Model Number: 903-3214
• Catalog Number: 903-3214
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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	03701037307854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162455

FDA Product Code

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

Sterilization

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

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

[03701037307854]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-26
• Device Publish Date: 2019-04-18

On-Brand Devices [HUMELOCK REVERSED]

• 03701037308004: TRIAL CENTERED TAPER ADAPTER Ø24 / Ø10
• 03701037307991: TRIAL ECCENTRIC TAPER ADAPTER Ø24 / Ø10
• 03701037307946: TRIAL HUMELOCK REVERSED STEM Ø36/16
• 03701037307861: TRIAL HUMELOCK REVERSED STEM Ø32/16
• 03701037307854: TRIAL HUMELOCK REVERSED STEMI Ø32/14
• 03701037303740: HUMELOCK REVERSED STEM TA6V Ø36/12 CEMENTLESS LOCKABLE Ti/HA