FDA UDI Not in Commercial Distribution 🇺🇸 United States

DBSWIN 5.11.0

DI: E247E72000 · Model: E7200 · DÜRR DENTAL SE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DBSWIN 5.11.0
Primary DI
E247E72000
Version / Model
E7200
Company Name
DÜRR DENTAL SE
Labeler DUNS
315563684
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
5
Public Version Date
2022-03-07
Public Version Status
Update
Public Device Record Key
61dad85b-eb22-4206-a38a-becd0d71d9bb
Distribution End Date
2022-03-04

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
No
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
LLZ System, Image Processing, Radiological

GMDN Terms

Code Name
40876 General-purpose dental x-ray system application software

Identifiers

Type ID
Primary E247E72000

Premarket Submissions

Submission Number Supplement Number
K161444 000