Offset Cup Impactor - M8x1 interface 01.15.10.0556

GUDID 07630055304971

Offset Cup Impactor for hip arthroplasty

Incipio Devices SA

Orthopaedic implant impactor, reusable

• Primary Device ID: 07630055304971
• NIH Device Record Key: d44418b8-bf6e-46a8-89d4-f3efba491c5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Offset Cup Impactor - M8x1 interface
• Version Model Number: 01.15.10.0556
• Catalog Number: 01.15.10.0556
• Company DUNS: 485098284
• Company Name: Incipio Devices SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	07630055304971 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630055304971]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-19
• Device Publish Date: 2024-02-09

On-Brand Devices [Offset Cup Impactor - M8x1 interface]

• 07630055302458: Offset Cup Impactor for hip arthroplasty
• 07630055304971: Offset Cup Impactor for hip arthroplasty