Device
Offset Reamer Handle drive chain accessory
Manufacturer
Incipio Devices SA
Model: 922061T-EZ Catalog: 50244510 DI: 07630055307033 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-07 Current Version: 2026-05-15
Description
Offset Reamer Handle drive chain accessory
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 5d33d077-8f73-47fc-8722-f8bc94ab6e31
Distribution Status: In Commercial Distribution
DUNS Number: 485098284
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 07630055307033
Type: Primary
Issuing Agency: GS1
GMDN
Code: 47845
Name: Surgical power tool adaptor
Definition:
A connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument