AccessGUDID - DEVICE: KaVo NOMAD Pro 2 (EKAV101377880)

GUDID

Device Identifier (DI) Information

Brand Name: KaVo NOMAD Pro 2
Version or Model: 1.013.7788
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dental Imaging Technologies Corporation

Primary DI Number: EKAV101377880
Issuing Agency: HIBCC
Commercial Distribution End Date: March 11, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 800111106 *Terms of Use

Device Description: KaVo NOMAD Pro 2, CA

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):	No
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?
37607	Diagnostic x-ray system generator, hand-held	An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a hand-held x-ray system, e.g., a system that is held during operation. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer and inverter generator designs. A hand-held x-ray system generators typically comprises a control assembly (console) and high voltage transformer assembly, but can also be a mono-tank generator design.	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 [?]
K173319	000

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: 6dad2857-47c7-4ad5-8b64-c7e807c18e59
Public Version Date: August 30, 2022
Public Version Number: 6
DI Record Publish Date: January 21, 2022