FDA UDI In Commercial Distribution 🇺🇸 United States

Liston Bone Cutter 22cm Single Action

DI: G25012063220 · Model: 12-063-22 · N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Liston Bone Cutter 22cm Single Action
Primary DI
G25012063220
Version / Model
12-063-22
Catalog Number
12-063-22
Company Name
N S SURGICAL COMPANY
Labeler DUNS
645681649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-03-28
Public Version
1
Public Version Date
2023-04-05
Public Version Status
New
Public Device Record Key
cd2731d0-b9bb-44b3-8044-dfacbf448371

Device Description

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.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
FZT Cutter, Surgical

GMDN Terms

Code Name
10455 Bone cutter

Identifiers

Type ID
Primary G25012063220

Device Sizes

Type Value Unit Text
Length 22 Centimeter