DEVICE: XIOS XG SELECT (D76464041691)
Device Identifier (DI) Information
XIOS XG SELECT
6404169
In Commercial Distribution
SIRONA DENTAL, INC.
6404169
In Commercial Distribution
SIRONA DENTAL, INC.
XIOS XG REPLACEABLE CABLE KIT, 90CM (3FT)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44905 | Dental digital imaging sensor, intraoral |
An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MUH | System,X-Ray,Extraoral Source,Digital |
MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
EHD | Unit, X-Ray, Extraoral With Timer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0f08adc1-ae02-4534-8281-ed2694cc7e24
December 09, 2022
5
September 09, 2016
December 09, 2022
5
September 09, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(877) 724-4254
customerserviceny@sirona.com
customerserviceny@sirona.com