Model: Z-1079
DI: 00197157081287
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
T-HANDLE, LARGE, SLIM FIXED HUDSON, BLACK
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:
c23d7f19-3da2-4bda-b755-bd123025dbda
Distribution Status:
In Commercial Distribution
DUNS Number:
069472800
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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
Device ID:
00197157081287
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62895
Name: Orthopaedic osteotome handle
Definition:
A hand-held component of an orthopaedic osteotome intended to be attached to an interchangeable blade (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. The operator holds this part of the instrument and manually imparts a force to it using a surgical mallet or hammer; it is made of metal and/or polymer materials. This is a reusable device.
FDA Product Codes
MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
Premarket Submissions
Submission Number:
K162496
Supplement Number:
000