AccessGUDID - DEVICE: Henry Schein® Super Concentrated General Purpose (D6871721362FG2)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein® Super Concentrated General Purpose
Version or Model: 1721362FG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1721362FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6871721362FG2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Henry Schein® Super Concetrated General Purpose - 16 oz

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
Storage Environment Temperature: between 22 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6 Bottles (16 oz)
Total Volume: 16 Fluid Ounce

Device Record Status

Public Device Record Key: 9b62e1da-f070-4bf0-a417-7343b4e2fd24
Public Version Date: April 04, 2023
Public Version Number: 6
DI Record Publish Date: September 21, 2016