Mpact DM Converter

GUDID 07630030812347

Double Mobility Converter Liner J/DMH

Medacta International SA

Metallic acetabular liner

• Primary Device ID: 07630030812347
• NIH Device Record Key: 322c1fc7-b7f1-47c3-8e85-346ad0165d0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mpact DM Converter
• Version Model Number: 01.32.4856MC
• 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	07630030812347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131458

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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