AccessGUDID - DEVICE: Cavex Individual Trays lowers plain (E241BL0560)

GUDID

Device Identifier (DI) Information

Brand Name: Cavex Individual Trays lowers plain
Version or Model: BL056
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BL056
Company Name: Cavex Holland B.V.

Primary DI Number: E241BL0560
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 419980156 *Terms of Use

Device Description: Dental Wax

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

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Product Code	Product Code Name
EEA	Plate, Base, Shellac

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
Storage Environment Temperature: between 0 and 25 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 1 pcs

Device Record Status

Public Device Record Key: c0e76401-08c2-46c7-800b-a84d8bba087c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 07, 2016