Device
RESCUE DRIVER, 5.0mm HEX, JACOBS-HALL/TRINKLE, CANNULATED
Manufacturer
ORTHO OUTCOMES, LLC
ORTHO OUTCOMES, LLC
Model: 104-0340-04
DI: 00850072364315
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
RESCUE DRIVER, 5.0mm HEX, JACOBS-HALL/TRINKLE, CANNULATED
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:
6e2b9a1a-2a7f-4d91-893a-1df5a75deedc
Distribution Status:
In Commercial Distribution
DUNS Number:
133439875
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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
Device ID:
00850072364315
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16077
Name: Orthopaedic bone bolt
Definition:
A short, implantable rod or shaft designed to be inserted through a long bone (excludes spinal bone) to secure the bone for traction or for a similar process/apparatus. The device is fastened with a nut/washer, and is typically made of metal or a polymer. It is typically used in the proximal tibia or distal femur. This is a single-use device.
FDA Product Codes
HWC
Screw, Fixation, Bone