FDA UDI In Commercial Distribution 🇺🇸 United States

ProVecta 3D Prime

DI: E247A77500 · Model: A7750 · DÜRR DENTAL SE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ProVecta 3D Prime
Primary DI
E247A77500
Version / Model
A7750
Company Name
DÜRR DENTAL SE
Labeler DUNS
315563684
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-02-02
Public Version
1
Public Version Date
2021-02-10
Public Version Status
New
Public Device Record Key
71184d1b-96e1-46c1-a7b7-483127797100

Device Description

X-Ray System

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
OAS X-Ray, Tomography, Computed, Dental

GMDN Terms

Code Name
61019 Cone beam computed tomography system, head/neck

Identifiers

Type ID
Primary E247A77500