AccessGUDID - DEVICE: Dr. Ronald Jordan Composite Instrument Series REJ #01 (07540172001021)

GUDID

Device Identifier (DI) Information

Brand Name: Dr. Ronald Jordan Composite Instrument Series REJ #01
Version or Model: 060101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 060101
Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Primary DI Number: 07540172001021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 626406016 *Terms of Use

Device Description: Dental restorative material applicator

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?
63953	Dental material application tool, reusable	A hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.	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
Storage Environment Temperature: less than 25 Degrees Celsius
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Length: 174 Millimeter
Device Size Text, specify: 1 x 174 mm instruments

Device Record Status

Public Device Record Key: 20fca527-22cb-4c08-9f83-a293a6a96271
Public Version Date: November 01, 2022
Public Version Number: 2
DI Record Publish Date: October 21, 2020