FDA UDI In Commercial Distribution 🇺🇸 United States

L&K Biomed DLIF PEEK Cage

DI: 08806344302389 · Model: 3842-6012 · L&K BIOMED CO. ,LTD.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
L&K Biomed DLIF PEEK Cage
Primary DI
08806344302389
Version / Model
3842-6012
Catalog Number
3842-6012
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
2015-11-16
Public Version
4
Public Version Date
2020-02-24
Public Version Status
Update
Public Device Record Key
b7f31879-207a-46f2-805d-5cc0dedf4401

Device Description

L&K Biomed DLIF PEEK Cage 20 x 60 12 12mm 1EA, LLIF PEEK Cage, 12︒,20x60x12mm

Device Characteristics

Single Use
Yes
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
No
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
Moist Heat or Steam Sterilization

Product Codes

Code Name
NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
KWP Appliance, Fixation, Spinal Interlaminal
KWQ Appliance, Fixation, Spinal Intervertebral Body
MNH Orthosis, Spondylolisthesis Spinal Fixation
MNI Orthosis, Spinal Pedicle Fixation

GMDN Terms

Code Name
60762 Polymeric spinal interbody fusion cage

Identifiers

Type ID
Primary 08806344302389