FDA UDI In Commercial Distribution 🇺🇸 United States

AMNOTEC

DI: 04250942101402 · Model: 71-068-05 NIR · AMNOTEC International Medical GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AMNOTEC
Primary DI
04250942101402
Version / Model
71-068-05 NIR
Catalog Number
71-068-05 NIR
Company Name
AMNOTEC International Medical GmbH
Labeler DUNS
342569940
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-01
Public Version
3
Public Version Date
2023-07-12
Public Version Status
Update
Public Device Record Key
78325f75-8aae-4044-bd35-5614229cd2b2

Device Description

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

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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 04250942101402