AccessGUDID - DEVICE: GL SINGLE THICKNESS WAFER (25) (D7752600311)

GUDID

Device Identifier (DI) Information

Brand Name: GL SINGLE THICKNESS WAFER (25)
Version or Model: 260-031
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 260-031
Company Name: Great Lakes Dental Technologies, Ltd.

Primary DI Number: D7752600311
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041854332 *Terms of Use

Device Description: GL SINGLE THICKNESS WAFER (25)

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?
38584	Bite registration rim wax, plate	A dental material (modelling wax) delivered as prefabricated plates of wax with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). 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: f9977d9d-5b45-4160-842c-41b89df374e2
Public Version Date: February 02, 2021
Public Version Number: 3
DI Record Publish Date: May 18, 2016