AccessGUDID - DEVICE: Hiflex Modelling Wax (D967130030)

GUDID

Device Identifier (DI) Information

Brand Name: Hiflex Modelling Wax
Version or Model: 24 sheets 500g
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13003
Company Name: PREVEST DENPRO LIMITED

Primary DI Number: D967130030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 859546940 *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?
63983	Denture trial fabrication wax	A material made primarily of wax, intended to be used in the dental laboratory to manufacture a trial denture/denture base. It is not intended to be used as an anatomical impression material nor is it intended to be used to manufacture a final dental prosthesis/appliance. It is commonly supplied in sheets and may be referred to as denture sheet wax. This is a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGD	Wax, Dental, Intraoral

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: da9d23d2-e3a9-4fa6-9c39-e4cd8fb29439
Public Version Date: December 27, 2022
Public Version Number: 1
DI Record Publish Date: December 19, 2022