Offset cup impactor - AR Nose 01.15.10.0546

GUDID 07630055304797

Nose accessory for offset cup impactor with anti-rotation feature

Incipio Devices SA

Orthopaedic implant impactor, reusable

• Primary Device ID: 07630055304797
• NIH Device Record Key: 8be36626-d990-46e3-8e11-b6c1f7fcbe82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Offset cup impactor - AR Nose
• Version Model Number: 01.15.10.0546
• Catalog Number: 01.15.10.0546
• 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	07630055304797 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

Moist Heat or Steam Sterilization

[07630055304797]

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

• 07630055307057 - Offset reamer handle - Stryker Z/H - Tri coupling: 2026-02-12 30° Offset Reamer Handle for hip arthroplasty
• 07630055300102 - Offset Cup Impactor - M8x1.25 Interface: 2026-02-09 Offset Cup Impactor - M8x1.25 Interface
• 07630055301369 - Offset Cup Impactor - M8x0.75 interface: 2026-02-09 Offset Cup Impactor for hip arthroplasty
• 07630055306296 - Straight reamer handle - large AO - Dual coupling (NL): 2026-02-06 Straight Acetabular Reamer Handle- for hip arthroplasty
• 07630055306302 - Straight reamer handle - Stryker Z/H - Dual coupling (NL): 2026-02-06 Straight Acetabular Reamer Handle- for hip arthroplasty
• 07630055306968 - Offset reamer handle - large AO - Dual Coupling: 2026-01-08 30° Offset Reamer Handle for hip arthroplasty
• 07630055306975 - Straight reamer handle - Large AO - Dual coupling: 2026-01-08 Straight Acetabular Reamer Handle- for hip arthroplasty
• 07630055307262 - Cup Reamer Size 42: 2025-12-29 Acetabular Reamer