Mpact DM Converter

GUDID 07630030812200

Double Mobility Converter Liner E/DMC

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

• Primary Device ID: 07630030812200
• NIH Device Record Key: 0f4475ba-9579-4af2-8f8d-9c50397e7530
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mpact DM Converter
• Version Model Number: 01.32.3844MC
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630030812200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131458

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-18

On-Brand Devices [Mpact DM Converter]

• 07630030812354: Double Mobility Converter Liner K/DML
• 07630030812347: Double Mobility Converter Liner J/DMH
• 07630030812330: Double Mobility Converter Liner G/DMF
• 07630030812323: Double Mobility Converter Liner F/DME
• 07630030812200: Double Mobility Converter Liner E/DMC
• 07630030812095: Double Mobility Converter Liner D/DMB