AccessGUDID - DEVICE: CEREC® Essentials featuring Preventive Solutions (D00261N0031)

GUDID

Device Identifier (DI) Information

Brand Name: CEREC® Essentials featuring Preventive Solutions
Version or Model: 61N003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 61N003
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00261N0031
Issuing Agency: HIBCC
Commercial Distribution End Date: June 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: CEREC® Omnicam High Level Disinfection Preventative Care Kit

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
47631	Medical device disinfection agent	A non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MED	Sterilant, medical devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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 10 and 24 Degrees Celsius
Special Storage Condition, Specify: Keep away from direct sunlight.
Special Storage Condition, Specify: Protect from moisture.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 HLD Tank and Cover, 2 plugs, 1 metal bracket, 3 protective caps, 1 container wipes, 1 box masks, 1 bottle Sporox II solution

Device Record Status

Public Device Record Key: 0c5a762c-0a38-4c3a-a2bf-6d309b5409d0
Public Version Date: June 05, 2024
Public Version Number: 3
DI Record Publish Date: May 24, 2022