FDA UDI In Commercial Distribution 🇺🇸 United States

XIOS AE

DI: D76467247491 · Model: 6724749 · SIRONA DENTAL, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
XIOS AE
Primary DI
D76467247491
Version / Model
6724749
Company Name
SIRONA DENTAL, INC.
Labeler DUNS
078613913
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-06
Public Version
2
Public Version Date
2022-12-09
Public Version Status
Update
Public Device Record Key
4533a5b3-eae1-4499-bb40-19e87150aaa0

Device Description

XIOS AE Sensor USB Size 0 270cm Cable

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
EHD Unit, X-Ray, Extraoral With Timer
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
MUH System, X-Ray, Extraoral Source, Digital

GMDN Terms

Code Name
44905 Dental digital imaging sensor, intraoral

Identifiers

Type ID
Primary D76467247491

Customer Contacts