AccessGUDID - DEVICE: RINN® (D0035547821)

GUDID

Device Identifier (DI) Information

Brand Name: RINN®
Version or Model: 554782
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dentsply International Inc.

Primary DI Number: D0035547821
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 795572718 *Terms of Use

Device Description: XCP-ORA® Toshiba #2. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® EVA Plus: 2 Horizontal Posterior Biteblocks, 2 Vertical Anterior Biteblocks, XCP-DS® Kodak: 2 Horizontal Bitewings with Biteblock, 2 Vertical Bitewings with Biteblock, Schick Elite: 2 Vertical Bitewings, 50 Bulk Sensor Covers.

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:	Yes
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
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEM	Dental barriers and sleeves
EGZ	Holder, film, x-ray

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4c6cae23-0c13-4f9a-926b-fa45e464026e
Public Version Date: September 11, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016