AccessGUDID - DEVICE: PRO3DURE GR-11 tray (EPRCD1001130)

GUDID

Device Identifier (DI) Information

Brand Name: PRO3DURE GR-11 tray
Version or Model: 1kg - Green
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D1001130
Company Name: pro3dure medical GmbH

Primary DI Number: EPRCD1001130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312947842 *Terms of Use

Device Description: printodent GR-11 tray

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):	Yes
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
EBH	Material, Impression Tray, Resin

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: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ac11afe-caab-4b25-a64f-f9a77a8b096a
Public Version Date: December 14, 2022
Public Version Number: 1
DI Record Publish Date: December 06, 2022