AccessGUDID - DEVICE: SmartPractice® Wares General Purpose Cleaner (D68721351FG2)

GUDID

Device Identifier (DI) Information

Brand Name: SmartPractice® Wares General Purpose Cleaner
Version or Model: 0821351FG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0821351FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D68721351FG2
Issuing Agency: HIBCC
Commercial Distribution End Date: June 05, 2024
Device Count: 4
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: SmartPractice® Wares General Purpose Cleaner, 1 Gallon

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:	No
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?
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
FLG	Cleaner, ultrasonic, medical instrument

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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 4 Bottles (3.8L)
Total Volume: 3.8 Liter

Device Record Status

Public Device Record Key: b24ac6b6-6d1b-4e88-b2d6-9068843895e5
Public Version Date: June 05, 2024
Public Version Number: 7
DI Record Publish Date: September 21, 2016