AccessGUDID - DEVICE: Sleeve for extraoral X-Ray devices (E27659682632)

GUDID

Device Identifier (DI) Information

Brand Name: Sleeve for extraoral X-Ray devices
Version or Model: 5968263
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SIRONA Dental Systems GmbH

Primary DI Number: E27659682632
Issuing Agency: HIBCC
Commercial Distribution End Date: October 13, 2023
Device Count: 500
Labeler D-U-N-S® Number*: 340306351 *Terms of Use

Device Description: Hygienic protective for forehead

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
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?
44245	Stationary panoramic/tomographic dental x-ray system, digital	A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAS	X-Ray, Tomography, Computed, 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: 0ce0ba2c-a33b-4bcb-8303-b29b5023ea63
Public Version Date: October 16, 2023
Public Version Number: 5
DI Record Publish Date: September 10, 2016