Offset Cup Impactor - M8x1.25 Interface 183-151/00

GUDID 07630055305053

Offset Cup Impactor - M8x1.25 Interface

Incipio Devices SA

Orthopaedic implant impactor, reusable

• Primary Device ID: 07630055305053
• NIH Device Record Key: bc3f9bef-2f0b-48f3-8fb8-9cfb4cf30a75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Offset Cup Impactor - M8x1.25 Interface
• Version Model Number: 183-151/00
• Catalog Number: 183-151/00
• 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	07630055305053 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[07630055305053]

Moist Heat or Steam Sterilization

[07630055305053]

Moist Heat or Steam Sterilization

[07630055305053]

Moist Heat or Steam Sterilization

[07630055305053]

Moist Heat or Steam Sterilization

[07630055305053]

Moist Heat or Steam Sterilization

[07630055305053]

Moist Heat or Steam Sterilization

[07630055305053]

Moist Heat or Steam Sterilization

[07630055305053]

Moist Heat or Steam Sterilization

[07630055305053]

Moist Heat or Steam Sterilization

[07630055305053]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-03
• Device Publish Date: 2024-12-26

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• 07630055305299 - ACE Acetabular Reamer 40mm: 2025-05-08 Acetabular Reamer
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• 07630055305312 - ACE Acetabular Reamer 42mm: 2025-05-08 Acetabular Reamer
• 07630055305329 - ACE Acetabular Reamer 43mm: 2025-05-08 Acetabular Reamer