AccessGUDID - DEVICE: PARAFFIN WAX (D080XXPRW500GLMCLE0)

GUDID

Device Identifier (DI) Information

Brand Name: PARAFFIN WAX
Version or Model: 500G,LARGE MEDIUM,CLEAR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: YAMAHACHI DENTAL MFG.,CO.

Primary DI Number: D080XXPRW500GLMCLE0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 693430001 *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:	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?
34808	Dental base plate	A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use 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: 98629740-2644-4368-aacb-009f8ea498d7
Public Version Date: November 09, 2023
Public Version Number: 3
DI Record Publish Date: October 02, 2023