AccessGUDID - DEVICE: Dentapen Cartridge holder (EJUVDP057)

GUDID

Device Identifier (DI) Information

Brand Name: Dentapen Cartridge holder
Version or Model: Cartridge hodler for Dentapen
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DP05
Company Name: JUVAPLUS SA

Primary DI Number: EJUVDP057
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 7
Labeler D-U-N-S® Number*: 486026102 *Terms of Use

Device Description: The non-sterile cartridge holder is used to connect the device to the cartridge. In order to ensure the quantity scale reading on the prefilled cartridge, the cartridge holder is transparent.

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:	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?
35969	Dental anaesthesia syringe, reusable	A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJI	Syringe, Cartridge

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: 029a8cc0-a303-451f-8722-0e4e7ca8be1b
Public Version Date: November 22, 2018
Public Version Number: 1
DI Record Publish Date: October 22, 2018