Offset reamer handle - Stryker Z/H - Tri coupling (NL) 50245118

GUDID 07630055300379

30° Offset Reamer Handle with non-locking reamer interface

Incipio Devices SA

Surgical power tool adaptor

• Primary Device ID: 07630055300379
• NIH Device Record Key: 441a6ad8-35c0-4977-b703-64e446b53d67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Offset reamer handle - Stryker Z/H - Tri coupling (NL)
• Version Model Number: 50245118
• Catalog Number: 50245118
• 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	07630055300379 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[07630055300379]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-16
• Device Publish Date: 2019-12-06

On-Brand Devices [Offset reamer handle - Stryker Z/H - Tri coupling (NL)]

• 07630055300379: 30° Offset Reamer Handle with non-locking reamer interface
• 07630055304865: Offset Reamer Handle for hip arthroplasty