AccessGUDID - DEVICE: 3.2 Mixing Tips with Integrated Needle 25-Pack (00359883002480)

GUDID

Device Identifier (DI) Information

Brand Name: 3.2 Mixing Tips with Integrated Needle 25-Pack
Version or Model: 032253
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 032253
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: 00359883002480
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: Dental material mixing nozzle, non-sterile

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?
58399	Dental material mixing nozzle	A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEW	TIP, RUBBER, ORAL HYGIENE

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
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3.2 Millimeter

Device Record Status

Public Device Record Key: 30de5be6-cc17-486a-bb64-dc00418b7091
Public Version Date: March 20, 2025
Public Version Number: 1
DI Record Publish Date: March 12, 2025