Henry Schein® Super Concentrated Enzymatic Cleaning Solution

Basic Information

• Brand Name: Henry Schein® Super Concentrated Enzymatic Cleaning Solution
• Primary DI: D6871721366FG2
• Version / Model: 1721366FG
• Catalog Number: 1721366FG
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 6
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 55adc9df-8161-4282-a79c-e5eb1e334938

Device Description

Henry Schein® Super Concentrated Enzymatic Cleaning Solution - 16 oz (60L)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLG	Cleaner, ultrasonic, medical instrument	General Hospital	880.6150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D6871721366FG2	HIBCC
Unit of Use	D6871721366FG0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	60	Liter
Device Size Text, specify			Six (16 oz) Bottles

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 65 – 85 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Do not ship or store below freezing.