Device
DEPTH GAGE, REUSABLE, 7.0mm
Manufacturer
ORTHO OUTCOMES, LLC
Model: 104-0270-05 DI: 00850072364230 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-11 Current Version: 2026-05-19
Description
DEPTH GAGE, REUSABLE, 7.0mm
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: 68830014-4928-470d-9464-ec46fbfd3a7d
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: 00850072364230
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