DEVICE: XIOS (D76461765511)

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Device Identifier (DI) Information

XIOS
6176551

SIRONA DENTAL, INC.
D76461765511
HIBCC
10
SIRONA ENDO HLDRR ASSY KIT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental x-ray film holder A device used during the taking of a dental x-ray and that is intended to allow insertion, positioning, stabilization, and removal of x-ray film used in either extraoral or intraoral dental imaging procedures. It holds the film whilst the x-ray is being taken. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
EAP Unit, X-Ray, Intraoral
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 09, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: D764B10730760 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

[?]
(877) 724-4254
customerserviceny@sirona.com
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