AccessGUDID - DEVICE: EVO 2 ST (08056865012834)

GUDID

Device Identifier (DI) Information

Brand Name: EVO 2 ST
Version or Model: EVO 2 ST 8 LOWER
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0120083
Company Name: DENTAL MANUFACTURING SPA

Primary DI Number: 08056865012834
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2024
Device Count: 8
Labeler D-U-N-S® Number*: 435782248 *Terms of Use

Device Description: No description.

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):	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?
38643	Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZY	Additively Manufactured, Preformed, Resin Denture Tooth

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: 8f925615-4c52-4846-91b8-2e058019f84f
Public Version Date: November 18, 2024
Public Version Number: 3
DI Record Publish Date: February 27, 2020