HUMERIS 931-1001

GUDID 03701037312445

TRIAL GLENOID SIZE XS

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037312445
• NIH Device Record Key: 57543fd0-5be4-4c0e-a316-fd93313462a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUMERIS
• Version Model Number: 931-1001
• Catalog Number: 931-1001
• 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	03701037312445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163669

FDA Product Code

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

Sterilization

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

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

Moist Heat or Steam Sterilization

[03701037312445]

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 [HUMERIS]

• 03701037312476: TRIAL GLENOID SIZE L
• 03701037312469: TRIAL GLENOID SIZE M
• 03701037312452: TRIAL GLENOID SIZE S
• 03701037312445: TRIAL GLENOID SIZE XS
• 03701037301722: 3-4 PEGS GLENOID PE CEMENTED SIZE L
• 03701037301715: 3-4 PEGS GLENOID PE CEMENTED SIZE M
• 03701037301708: 3-4 PEGS GLENOID PE CEMENTED SIZE S
• 03701037301692: 3-4 PEGS GLENOID PE CEMENTED SIZE XS