AccessGUDID - DEVICE: Compules Tips Gun (D010606659001)

GUDID

Device Identifier (DI) Information

Brand Name: Compules Tips Gun
Version or Model: 60665900
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60665900
Company Name: Dentsply De Trey GmbH

Primary DI Number: D010606659001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315471722 *Terms of Use

Device Description: Compules Tips Gun is an applicator gun for all Dentsply Sirona materials delivered in Compules Tips and Compula Tips.

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?
16196	Dental material cartridge-plunging applicator, single-component	A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	INSTRUMENTS, DENTAL HAND

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: 38060306-d14c-4080-a9ce-75ea3eeccecd
Public Version Date: October 21, 2024
Public Version Number: 9
DI Record Publish Date: August 10, 2023