DEVICE: Sirocam UAF Plus (D7641000064690)

Device Identifier (DI) Information

Sirocam UAF Plus
100006469
Not in Commercial Distribution

SIRONA DENTAL, INC.
D7641000064690
HIBCC
March 23, 2022
1
078613913 *Terms of Use
Sirocam UAF Plus Handpiece With Cable
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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?
40983 Diagnostic-imaging photographic film, self-developing
A self-developing photographic film (e.g., instant or Polaroid) specifically designed for use in a dedicated camera and used for medical or dental imaging applications; especially where it is advantageous to see if the image captured reflects the best possible or intended view of the actual situation of the moment. It is typically designed with specific archival properties that determine the useful life of images captured on the medium.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EIA Unit, Operative Dental
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8d4c4707-1480-4a2d-bc76-b1b70c369a65
December 09, 2022
4
May 10, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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