Model: CI-11995-11
DI: 00840180546390
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Posterior 15 Degree Lordotic Shaver 11mm
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:
526c619f-510d-42f2-8774-9a025ae3da62
Distribution Status:
In Commercial Distribution
DUNS Number:
602465783
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
Device ID:
00840180546390
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 10455
Name: Bone cutter
Definition:
A strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.
FDA Product Codes
HTZ
INSTRUMENT, CUTTING, ORTHOPEDIC