FDA UDI In Commercial Distribution 🇺🇸 United States

VEQTRON

DI: 06973031299702 · Model: 71-068-05 NIR · Guangdong Optomedic Technologies, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VEQTRON
Primary DI
06973031299702
Version / Model
71-068-05 NIR
Catalog Number
71-068-05 NIR
Company Name
Guangdong Optomedic Technologies, Inc.
Labeler DUNS
544527790
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-11-11
Public Version
2
Public Version Date
2023-12-06
Public Version Status
Update
Public Device Record Key
ad22045d-7091-468a-998d-e5c9e4e20c0c

Device Description

VEQTRON ICG/NIR 4K UHD Endoscopic Fluorescence Imaging System, 4 CMOS, Camera Control Unit

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GCJ Laparoscope, General & Plastic Surgery
IZI System, X-Ray, Angiographic

GMDN Terms

Code Name
37679 Stationary general-purpose fluoroscopic x-ray system, digital

Identifiers

Type ID
Primary 06973031299702

Premarket Submissions

Submission Number Supplement Number
K221861 000