AccessGUDID - DEVICE: RINN® (D0035500711)

GUDID

Device Identifier (DI) Information

Brand Name: RINN®
Version or Model: 550071
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 550071
Company Name: Dentsply International Inc.

Primary DI Number: D0035500711
Issuing Agency: HIBCC
Commercial Distribution End Date: February 21, 2024
Device Count: 2
Labeler D-U-N-S® Number*: 795572718 *Terms of Use

Device Description: RINN® XCP-ORA® Single In Bag

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?
16205	Dental x-ray film holder, reusable	A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHA	Aligner, beam, x-ray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 7b47cb67-340f-46cf-8060-187182fa1140
Public Version Date: February 22, 2024
Public Version Number: 2
DI Record Publish Date: November 27, 2022