AccessGUDID - DEVICE: RINN® (D6475408531)

GUDID

Device Identifier (DI) Information

Brand Name: RINN®
Version or Model: 540853
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dentsply International Inc.

Primary DI Number: D6475408531
Issuing Agency: HIBCC
Commercial Distribution End Date: February 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 795572718 *Terms of Use

Device Description: UNIVERSAL COLLIMATOR

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?
40960	Dental x-ray system collimator	A beam restriction device used in dental x-ray systems to determine the dimension and direction of the x-ray beam, limiting the effects of scattered radiation. It is used to control the size and shape of the x-ray beam reaching the patient's oral cavity and the film or image receptor. It includes all kinds of x-ray beam restriction devices used in diagnostic dental x-ray systems, such as cones and slit collimators. The device is typically designed for use with a specific dental x-ray system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZX	Collimator, manual, radiographic

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: 6d06890b-771b-4104-b394-b4a683c0721e
Public Version Date: February 29, 2024
Public Version Number: 5
DI Record Publish Date: September 23, 2016