AccessGUDID - DEVICE: Sirocam UAF Plus (D7641000064690)

GUDID

Device Identifier (DI) Information

Brand Name: Sirocam UAF Plus
Version or Model: 100006469
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SIRONA DENTAL, INC.

Primary DI Number: D7641000064690
Issuing Agency: HIBCC
Commercial Distribution End Date: March 23, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 078613913 *Terms of Use

Device Description: Sirocam UAF Plus Handpiece With Cable

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, Operative Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8d4c4707-1480-4a2d-bc76-b1b70c369a65
Public Version Date: December 09, 2022
Public Version Number: 4
DI Record Publish Date: May 10, 2018