FDA UDI In Commercial Distribution 🇺🇸 United States

FONA ART Plus

DI: E3158468260320 · Model: 8468260320 · BLUO ELECTRONICS SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
FONA ART Plus
Primary DI
E3158468260320
Version / Model
8468260320
Catalog Number
9768261020
Company Name
BLUO ELECTRONICS SRL
Labeler DUNS
514320345
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-12
Public Version
2
Public Version Date
2023-07-28
Public Version Status
Update
Public Device Record Key
f5fb53e1-74f2-4464-bdb0-4404232f60cc

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
MUH System, X-Ray, Extraoral Source, Digital

GMDN Terms

Code Name
43369 Stationary panoramic dental x-ray system, digital

Identifiers

Type ID
Primary E3158468260320