AccessGUDID - DEVICE: Denticator (00302730002393)

GUDID

Device Identifier (DI) Information

Brand Name: Denticator
Version or Model: 670450
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 670450
Company Name: YOUNG DENTAL MANUFACTURING I, LLC

Primary DI Number: 00302730002393
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 006309355 *Terms of Use

Device Description: Denticator Low Speed Handpiece Sleeve, Infection Control Barrier

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):	No
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 [?]
K151123	000

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: fdd217d9-fa7c-4636-8231-a52080b3e126
Public Version Date: January 20, 2025
Public Version Number: 5
DI Record Publish Date: October 16, 2022