AccessGUDID - DEVICE: Wagotrix (00850028211434)

GUDID

Device Identifier (DI) Information

Brand Name: Wagotrix
Version or Model: WGSMIK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WGSMIK
Company Name: GoldenDent

Primary DI Number: 00850028211434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078273228 *Terms of Use

Device Description: WagoTrix Sectional Matrix System Intro Kit includes: 3.5 Anatomical Matrix Refill - Qty 25, 4.5 Anatomical Matrix Refill - Qty 25, 5.5 Anatomical Matrix Refill - Qty 25, 6.5 Anatomical Matrix Refill - Qty 25, Wedge - Small - Qty 25, Wedge - Medium - Qty 25, Wedge - Large - Qty 25, Matrix Ring Universal - Qty 35, Matrix Pin Holder - Qty 1, Matrix Ring Forceps - Qty 1

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:	Yes
Combination Product:	Yes
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?
62764	Dental matrix band kit	A collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEP	RETAINER, MATRIX
EKF	INSTRUMENT, CONTOURING, MATRIX, OPERATIVE
EJB	HANDLE, INSTRUMENT, DENTAL
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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: c941c474-d771-40de-bafd-de69c89c2911
Public Version Date: March 05, 2021
Public Version Number: 1
DI Record Publish Date: February 25, 2021