Positioning handle - M8x0.75 interface 50341432

GUDID 07630055304711

Accessory positioning handle for Offset Cup Impactor

Incipio Devices SA

Orthopaedic implant impactor

• Primary Device ID: 07630055304711
• NIH Device Record Key: 45b5f696-7993-4a1d-8c5c-6403092dd0cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Positioning handle - M8x0.75 interface
• Version Model Number: 50341432
• Catalog Number: 50341432
• 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	07630055304711 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

[07630055304711]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [Positioning handle - M8x0.75 interface]

• 07630055304711: Accessory positioning handle for Offset Cup Impactor
• 07630055304704: Accessory positioning handle for Offset Cup Impactor