FDA UDI In Commercial Distribution 🇺🇸 United States

ORTHOPHOS SL

DI: E27664649650 · Model: 6464965 · SIRONA Dental Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ORTHOPHOS SL
Primary DI
E27664649650
Version / Model
6464965
Company Name
SIRONA Dental Systems GmbH
Labeler DUNS
340306351
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-10
Public Version
5
Public Version Date
2022-05-17
Public Version Status
Update
Public Device Record Key
cc1540c0-64f3-4db2-aa92-dc0bc7cb4428

Device Description

OP SL 3D 8x8

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 E27664649650

Customer Contacts

Phone
+4962511670