AccessGUDID - DEVICE: Cavex ImpreSafe container (E241HT0200)

GUDID

Device Identifier (DI) Information

Brand Name: Cavex ImpreSafe container
Version or Model: HT020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HT020
Company Name: Cavex Holland B.V.

Primary DI Number: E241HT0200
Issuing Agency: HIBCC
Commercial Distribution End Date: March 04, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 419980156 *Terms of Use

Device Description: Dental impression disinfectant

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35871	Denture cleanser	An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, Medical Devices

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
Device Size Text, specify: 1 pcs

Device Record Status

Public Device Record Key: 48bad82a-5ec8-4df8-ba45-be2cac7135c2
Public Version Date: March 05, 2026
Public Version Number: 4
DI Record Publish Date: July 07, 2016