FDA UDI In Commercial Distribution 🇺🇸 United States

DIAGNOcam Vision Full HD

DI: EKAV101315000 · Model: 1.013.1500 · KaVo Dental GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DIAGNOcam Vision Full HD
Primary DI
EKAV101315000
Version / Model
1.013.1500
Catalog Number
1.013.1500
Company Name
KaVo Dental GmbH
Labeler DUNS
333710619
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-02-01
Public Version
1
Public Version Date
2024-02-09
Public Version Status
New
Public Device Record Key
819a33cd-6f72-4d2a-ab41-13c194fa0067

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
Yes
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
NBL Laser, fluorescence caries detection
NTK Caries detector, laser light, transmission

GMDN Terms

Code Name
33995 Dental caries detector, optical induced fluorescence

Identifiers

Type ID
Primary EKAV101315000