DM Converter – TiN coated

GUDID 07630971256361

DM Converter F/DME - TiN coated

Medacta International SA

Metallic acetabular liner

• Primary Device ID: 07630971256361
• NIH Device Record Key: 3a544c9d-1c00-4a66-a790-69b707f4e835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DM Converter – TiN coated
• Version Model Number: 01.32.4248CF
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630971256361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211891

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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: 2022-08-02
• Device Publish Date: 2022-07-25

On-Brand Devices [DM Converter – TiN coated]

• 07630971256392: DM Converter K/DML - TiN coated
• 07630971256385: DM Converter J/DMH - TiN coated
• 07630971256378: DM Converter G/DMF - TiN coated
• 07630971256361: DM Converter F/DME - TiN coated
• 07630971256354: DM Converter E/DMC - TiN coated
• 07630971256347: DM Converter D/DMB - TiN coated