AGILON® XO PE-glenoid cemented

GUDID 04048844546670

implantcast GmbH

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 04048844546670
• NIH Device Record Key: 0588570b-d2bb-4bf3-aa44-559e95c06fd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGILON® XO PE-glenoid cemented
• Version Model Number: 38030136
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04048844546670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222482

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-12
• Device Publish Date: 2022-10-04

On-Brand Devices [AGILON® XO PE-glenoid cemented]

• 04048844546687: 38030140
• 04048844546670: 38030136
• 04048844546663: 38030132
• 04048844546656: 38030128