AccessGUDID - DEVICE: ROGSON WAX, MDC Dental (07506338303316)

GUDID

Device Identifier (DI) Information

Brand Name: ROGSON WAX, MDC Dental
Version or Model: Self-Adhering Plastic Form
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MDC DENTAL

Primary DI Number: 07506338303316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 811180298 *Terms of Use

Device Description: Rogson Wax, Corrugated Self-Adhering Plastic Form, 24 Caliber 24GA CRS with 8 sheets

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):	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
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: 3983d72e-6534-4db7-90d7-fedaf14ab0fb
Public Version Date: February 23, 2024
Public Version Number: 1
DI Record Publish Date: February 15, 2024