DM Converter – TiN coated

GUDID 07630971256378

DM Converter G/DMF - TiN coated

Medacta International SA

Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner

• Primary Device ID: 07630971256378
• NIH Device Record Key: 7c9e50a6-9def-4d9a-abe5-d14207d73c5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DM Converter – TiN coated
• Version Model Number: 01.32.4452CF
• 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	07630971256378 [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