Model: 02-RR-HANDLE
Catalog: 02-RR-HANDLE
DI: 00840311251261
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Rapid Reducer, Counter Torque Handle
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:
49ade3c9-464d-4a14-a250-4e09c5531742
Distribution Status:
In Commercial Distribution
DUNS Number:
081224143
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00840311251261
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00846468006228
Item #2 - Device ID Type:
Previous
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 47829
Name: Surgical instrument handle, non-torque-limiting
Definition:
A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.
FDA Product Codes
LXH
Orthopedic manual surgical instrument