Positioning handle - 3/8-16 interface 10-503-411-34

GUDID 07630055304742

Positioning handle assembly accessory for offset cup impactor 3/8-16 interface

Incipio Devices SA

Orthopaedic implant impactor, reusable

• Primary Device ID: 07630055304742
• NIH Device Record Key: c4a685fb-1d04-4e82-9074-0db191c023a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Positioning handle - 3/8-16 interface
• Version Model Number: 50341134
• Catalog Number: 10-503-411-34
• 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	07630055304742 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

[07630055304742]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-16
• Device Publish Date: 2023-10-06

Devices Manufactured by Incipio Devices SA

• 07630055305251 - ACE Acetabular Reamer 36mm: 2025-05-08 Acetabular Reamer
• 07630055305268 - ACE Acetabular Reamer 37mm: 2025-05-08 Acetabular Reamer
• 07630055305275 - ACE Acetabular Reamer 38mm: 2025-05-08 Acetabular Reamer
• 07630055305282 - ACE Acetabular Reamer 39mm: 2025-05-08 Acetabular Reamer
• 07630055305299 - ACE Acetabular Reamer 40mm: 2025-05-08 Acetabular Reamer
• 07630055305305 - ACE Acetabular Reamer 41mm: 2025-05-08 Acetabular Reamer
• 07630055305312 - ACE Acetabular Reamer 42mm: 2025-05-08 Acetabular Reamer
• 07630055305329 - ACE Acetabular Reamer 43mm: 2025-05-08 Acetabular Reamer