AccessGUDID - DEVICE: StarDental Instrument Solutions (D702RT3003860)

GUDID

Device Identifier (DI) Information

Brand Name: StarDental Instrument Solutions
Version or Model: RT3-00386
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DENTALEZ, INC.

Primary DI Number: D702RT3003860
Issuing Agency: HIBCC
Commercial Distribution End Date: July 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 059010363 *Terms of Use

Device Description: Identafi Dealer Demo Kit

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?
60827	Oral lesion examination light	A battery-powered, hand-held, torch-like device designed to visualize, and facilitate identification of, abnormalities of the oral mucosa (e.g., malignancy, dysplasia, bacterial and fungal infections) using one or more wavelengths (colours) of light. It may be supplied with disposable accessories (e.g., mirrors, tinted spectacles, lens covers). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXV	Diagnostic Light, Soft Tissue Detector

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: ad6a2ceb-9490-4c82-861b-bafa77dc2737
Public Version Date: July 14, 2023
Public Version Number: 4
DI Record Publish Date: September 13, 2016