FDA UDI Not in Commercial Distribution 🇺🇸 United States

NOMAD Pro2 Packaged X-Ray System Black-R

DI: EKAV085006220 · Model: 0.850.0622 · Dental Imaging Technologies Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NOMAD Pro2 Packaged X-Ray System Black-R
Primary DI
EKAV085006220
Version / Model
0.850.0622
Company Name
Dental Imaging Technologies Corporation
Labeler DUNS
800111106
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-01-21
Public Version
6
Public Version Date
2022-08-30
Public Version Status
Update
Public Device Record Key
2ed18d68-c9a9-4284-b9a8-b989fcee8668
Distribution End Date
2022-03-11

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EHD Unit, X-Ray, Extraoral With Timer

GMDN Terms

Code Name
37607 Diagnostic x-ray system generator, hand-held

Identifiers

Type ID
Primary EKAV085006220

Premarket Submissions

Submission Number Supplement Number
K173319 000