AccessGUDID - DEVICE: TEMREX MATRIX RETAINER (00850015110627)

GUDID

Device Identifier (DI) Information

Brand Name: TEMREX MATRIX RETAINER
Version or Model: 97, 98, 99, 100, 101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TEMREX CORPORATION

Primary DI Number: 00850015110627
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012072823 *Terms of Use

Device Description: A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration.

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?
33204	Dental matrix band retainer	A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9c401686-cc3b-413b-922a-df24986bc988
Public Version Date: March 17, 2022
Public Version Number: 1
DI Record Publish Date: March 09, 2022