AccessGUDID - DEVICE: RINN® (D003MK05001)

GUDID

Device Identifier (DI) Information

Brand Name: RINN®
Version or Model: MK-0500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dentsply International Inc.

Primary DI Number: D003MK05001
Issuing Agency: HIBCC
Commercial Distribution End Date: December 01, 2022
Device Count: 5
Labeler D-U-N-S® Number*: 795572718 *Terms of Use

Device Description: Rinn® Universal Sensor Cover, 5 count

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:	Yes
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?
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

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
Special Storage Condition, Specify: Store at room temperature, out of direct sunlight. Store in a cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4a77e744-495e-4d25-a6f7-1d1f4665f026
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: November 11, 2016