FDA UDI In Commercial Distribution 🇺🇸 United States

VorOtek LED HeadLight

DI: 09348227000290 · Model: VLHH-D · VOROTEK PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VorOtek LED HeadLight
Primary DI
09348227000290
Version / Model
VLHH-D
Catalog Number
VLHH-D
Company Name
VOROTEK PTY LTD
Labeler DUNS
744332997
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-08
Public Version
1
Public Version Date
2023-08-16
Public Version Status
New
Public Device Record Key
3fd99636-f012-4c47-98cf-ac3a8473df94

Device Description

VorOtek LED HeadLight Fixed Spot - HeadBand. Fully Portable Surgical Quality Dimmable LED Illumination with Fixed Spot Size. Includes Power Pack, Charger & Carry Case.

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HPP Headlamp, Operating, Battery-Operated

GMDN Terms

Code Name
46807 Head-worn lamp

Identifiers

Type ID
Primary 09348227000290