HUMERIS 400-1101

GUDID 03701037301692

3-4 PEGS GLENOID PE CEMENTED SIZE XS

FX SOLUTIONS

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 03701037301692
• NIH Device Record Key: 7bb790db-0b03-4fce-9e04-29ffad81c902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUMERIS
• Version Model Number: 3-4 PEGS GLENOID PE CEMENTED SIZE XS
• Catalog Number: 400-1101
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037301692 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163669

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-05-22

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