AccessGUDID - DEVICE: PremEco Line set-up wax, 95g (D7091030076)

GUDID

Device Identifier (DI) Information

Brand Name: PremEco Line set-up wax, 95g
Version or Model: PremEco Line set-up wax, 95g
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1030076
Company Name: Merz Dental GmbH

Primary DI Number: D7091030076
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 324914910 *Terms of Use

Device Description: PremEco Line set-up wax, 95g

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?
16189	Dental casting wax	A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6d23227d-c5a1-4f07-aebf-b1533be3eda4
Public Version Date: January 30, 2025
Public Version Number: 3
DI Record Publish Date: May 29, 2020