FDA UDI In Commercial Distribution 🇺🇸 United States

LnK Spinal Instrument System

DI: 08800108667158 · Model: LC04-0110H · L&K BIOMED CO. ,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LnK Spinal Instrument System
Primary DI
08800108667158
Version / Model
LC04-0110H
Catalog Number
LC04-0110H
Company Name
L&K BIOMED CO. ,LTD.
Labeler DUNS
631159324
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-09
Public Version
1
Public Version Date
2023-06-19
Public Version Status
New
Public Device Record Key
3595aa76-d0ea-4d11-ac89-9c1985df9cf4

Device Description

TRIAL WITH RASP ANGLED 18W/10MM

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
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
35559 Bone file/rasp, manual, reusable

Identifiers

Type ID
Primary 08800108667158