FDA UDI In Commercial Distribution 🇺🇸 United States

Orthophos S

DI: E27667333770 · Model: 6733377 · SIRONA Dental Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Orthophos S
Primary DI
E27667333770
Version / Model
6733377
Company Name
SIRONA Dental Systems GmbH
Labeler DUNS
340306351
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-09-01
Public Version
2
Public Version Date
2022-05-17
Public Version Status
Update
Public Device Record Key
7538e453-0eed-4e5e-80df-40ebd7e4d819

Device Description

Orthophos S 2D (without Galileos Implant & without RCU)

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
44245 Stationary panoramic/tomographic dental x-ray system, digital

Identifiers

Type ID
Primary E27667333770

Customer Contacts

Phone
+4962511670