AccessGUDID - DEVICE: ThermTray1 Anterior (00859787002109)

GUDID

Device Identifier (DI) Information

Brand Name: ThermTray1 Anterior
Version or Model: 120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ADVANTAGE DENTAL PRODUCTS INC

Primary DI Number: 00859787002109
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2021
Device Count: 20
Labeler D-U-N-S® Number*: 607859147 *Terms of Use

Device Description: Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression materials.

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:	Yes
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?
16350	Dental impression tray, single-use	A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHY	Tray, Impression, Preformed

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
Special Storage Condition, Specify: Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
Storage Environment Temperature: less than 125 Degrees Fahrenheit
Handling Environment Temperature: less than 125 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61a6d4a6-840d-490b-8264-88f33e1a9584
Public Version Date: June 16, 2023
Public Version Number: 3
DI Record Publish Date: November 04, 2016