ACE Acetabular Reamer 53mm 00-501-410-53

GUDID 07630055305428

Acetabular Reamer

Incipio Devices SA

Acetabular orthopaedic reamer

• Primary Device ID: 07630055305428
• NIH Device Record Key: d1de6a7b-1d66-4797-ba06-a0c5bb37bd6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE Acetabular Reamer 53mm
• Version Model Number: 50141053
• Catalog Number: 00-501-410-53
• 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 Dimensions

• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630055305428 [Primary]

FDA Product Code

• HTO: Reamer

Sterilization

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

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

[07630055305428]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-08
• Device Publish Date: 2025-04-30

Devices Manufactured by Incipio Devices SA

• 07630055303684 - 50° Offset reamer handle - Stryker Z/H - Tri coupling: 2025-12-08 50° Offset Reamer Handle for hip arthroplasty
• 07630055303691 - 50° Offset reamer handle - Stryker Z/H - Tri coupling (NL): 2025-12-08 50° Offset Reamer Handle for hip arthroplasty
• 07630055303714 - 55° Angled reamer handle - Hudson - Tri coupling (NC): 2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
• 07630055303721 - 55° Angled reamer handle - Hudson - Tri coupling (NL): 2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
• 07630055303745 - 55° Angled reamer handle - large AO - Tri coupling (NC): 2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
• 07630055303752 - 55° Angled reamer handle - large AO - Tri coupling (NL): 2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
• 07630055303776 - 55° Angled reamer handle - Stryker Z/H - Tri coupling (NC): 2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
• 07630055303783 - 55° Angled reamer handle - Stryker Z/H - Tri coupling (NL): 2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery