Offset reamer handle - Tri coupling transmission (NC) 50244520

GUDID 07630055304513

Offset Reamer Handle drive chain accessory

Incipio Devices SA

Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor

• Primary Device ID: 07630055304513
• NIH Device Record Key: 5ca96da4-fc14-4f92-8aa2-349d38bcd39d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Offset reamer handle - Tri coupling transmission (NC)
• Version Model Number: 50244520
• Catalog Number: 50244520
• 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	07630055304513 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[07630055304513]

Moist Heat or Steam Sterilization

[07630055304513]

Moist Heat or Steam Sterilization

[07630055304513]

Moist Heat or Steam Sterilization

[07630055304513]

Moist Heat or Steam Sterilization

[07630055304513]

Moist Heat or Steam Sterilization

[07630055304513]

Moist Heat or Steam Sterilization

[07630055304513]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-13
• Device Publish Date: 2022-06-03

Devices Manufactured by Incipio Devices SA

• 07630055304995 - Offset reamer handle - Dual coupling: 2024-04-22 Offset reamer handle core assembly without power coupling
• 07630055305008 - Offset reamer handle - Dual coupling transmission: 2024-04-22 Drive chain accessory for offset reamer handles
• 07630055304780 - Offset Cup Impactor - 3/8-24 interface: 2024-03-26 Offset Cup Impactor for hip arthroplasty
• 07630055304933 - Positioning handle - M10x1.5 interface: 2024-03-20 Positioning handle assembly accessory for offset cup impactor M10x1.5 interface
• 07630055305107 - Offset Cup Impactor - M10x1.5 interface: 2024-03-20 Offset Cup Impactor for hip arthroplasty
• 07630055305190 - Offset Reamer Handle - Handle: 2024-02-29 Handle accessory for offset reamer handles
• 07630055305206 - Offset Reamer Handle - Body: 2024-02-29 Body accessory for offset reamer handles
• 07630055305213 - Offset reamer handle - Stryker Z/H motor shaft: 2024-02-29 Offset Reamer Handle power coupling accessory