FDA UDI In Commercial Distribution 🇺🇸 United States

K2M Cayon Retractor System Port Illuminator 26mm

DI: 00812432021283 · Model: 012065 · LUMITEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
K2M Cayon Retractor System Port Illuminator 26mm
Primary DI
00812432021283
Version / Model
012065
Catalog Number
AN01-90018
Company Name
LUMITEX, INC.
Labeler DUNS
108631797
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-02-06
Public Version
2
Public Version Date
2023-08-29
Public Version Status
Update
Public Device Record Key
bb9fd4cb-00e3-453c-a518-f0a47e52c8c9

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FDG Retractor, Fiberoptic

GMDN Terms

Code Name
65349 Open surgical site internal light

Identifiers

Type ID
Primary 00812432021283