AccessGUDID - DEVICE: Impression Trays Perforated (G429A4290)

GUDID

Device Identifier (DI) Information

Brand Name: Impression Trays Perforated
Version or Model: A429
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEED SKILL SURGICAL

Primary DI Number: G429A4290
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645670493 *Terms of Use

Device Description: Impression trays are dental instruments which are used to hold the Impression material in place to take a Impression of the tissue surfaces in the oral cavity, the impression trays are mainly used in Prosthodontics and used in Orthodontics to take impression of the Dentulous teeth.

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?
35850	Dental impression tray, reusable	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 reusable 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: Yes

Sterilization Method [?]
Ethylene Oxide
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: c83404e5-a1c5-4f95-8457-0ac7f20430be
Public Version Date: January 17, 2023
Public Version Number: 1
DI Record Publish Date: January 09, 2023