Offset Reamer Handle - Dual Coupling 90CH.IN.004 00

GUDID 07630055300393

Offset Reamer Handle - Dual Coupling, Core system sold without power attachment

Incipio Devices SA

Surgical power tool adaptor

• Primary Device ID: 07630055300393
• NIH Device Record Key: 82b8f829-04b9-4f3e-805d-64c03a77bd64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Offset Reamer Handle - Dual Coupling
• Version Model Number: 90CH.IN.004 00
• Catalog Number: 90CH.IN.004 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	07630055300393 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[07630055300393]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-24
• Device Publish Date: 2020-02-14

On-Brand Devices [Offset Reamer Handle - Dual Coupling]

• 07630055300393: Offset Reamer Handle - Dual Coupling, Core system sold without power attachment
• 07630055304995: Offset reamer handle core assembly without power coupling