Positioning handle - M8x1 interface 75.70.057

GUDID 07630055304612

Positioning handle assembly accessory for offset cup impactor M8x1 interface

Incipio Devices SA

Orthopaedic implant impactor, reusable

• Primary Device ID: 07630055304612
• NIH Device Record Key: 262182a7-ee52-417b-99b3-b1bbfe5ea057
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Positioning handle - M8x1 interface
• Version Model Number: 75.70.057
• Catalog Number: 75.70.057
• 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	07630055304612 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[07630055304612]

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

Devices Manufactured by Incipio Devices SA

• 07630055305053 - Offset Cup Impactor - M8x1.25 Interface: 2025-01-03 Offset Cup Impactor - M8x1.25 Interface
• 07630055305015 - Positioning handle - M6x1 interface: 2024-07-05 Positioning handle assembly accessory for offset cup impactor M6x1 interface
• 07630055305237 - Positioning handle - M6x1 interface: 2024-07-05 Positioning handle assembly accessory for offset cup impactor M6x1 interface
• 07630055304995 - Offset reamer handle - Dual coupling: 2024-04-22 Offset reamer handle core assembly without power coupling
• 07630055305008 - Offset reamer handle - Dual coupling transmission: 2024-04-22 Drive chain accessory for offset reamer handles
• 07630055304780 - Offset Cup Impactor - 3/8-24 interface: 2024-03-26 Offset Cup Impactor for hip arthroplasty
• 07630055304933 - Positioning handle - M10x1.5 interface: 2024-03-20 Positioning handle assembly accessory for offset cup impactor M10x1.5 interface
• 07630055305107 - Offset Cup Impactor - M10x1.5 interface: 2024-03-20 Offset Cup Impactor for hip arthroplasty