AccessGUDID - DEVICE: ORTHOPHOS XG (E27662812450)

GUDID

Device Identifier (DI) Information

Brand Name: ORTHOPHOS XG
Version or Model: 6281245
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SIRONA Dental Systems GmbH

Primary DI Number: E27662812450
Issuing Agency: HIBCC
Commercial Distribution End Date: May 14, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 340306351 *Terms of Use

Device Description: ORTHOPHOS XG 3D ready Ceph

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:	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?
43369	Stationary panoramic 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 to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHD	Unit, X-Ray, Extraoral With Timer

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: 713154e5-cb1a-4552-a931-a7a3f487f206
Public Version Date: May 17, 2022
Public Version Number: 4
DI Record Publish Date: September 10, 2016