Mpact Double Mobility Shells

GUDID 07630030860997

Double Mobility Acetabular shell Ø56

Medacta International SA

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 07630030860997
• NIH Device Record Key: a13df391-ee06-4e53-a385-d65cfe88a965
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mpact Double Mobility Shells
• Version Model Number: 01.32.156MB
• 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	07630030860997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143453

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2015-09-21

On-Brand Devices [Mpact Double Mobility Shells]

• 07630030861048: Double Mobility Acetabular shell Ø66
• 07630030861031: Double Mobility Acetabular shell Ø64
• 07630030861024: Double Mobility Acetabular shell Ø62
• 07630030861017: Double Mobility Acetabular shell Ø60
• 07630030861000: Double Mobility Acetabular shell Ø58
• 07630030860997: Double Mobility Acetabular shell Ø56
• 07630030860980: Double Mobility Acetabular shell Ø54
• 07630030860973: Double Mobility Acetabular shell Ø52
• 07630030860966: Double Mobility Acetabular shell Ø50
• 07630030860959: Double Mobility Acetabular shell Ø48
• 07630030860942: Double Mobility Acetabular shell Ø46
• 07630030860935: Double Mobility Acetabular shell Ø44
• 07630030860928: Double Mobility Acetabular shell Ø42