FDA.reportPublic FDA data

Pearson Quality Enzymatic Ultrasonic Cleaning Solution

Primary DI
D6872221366FG1
Brand
Pearson Quality Enzymatic Ultrasonic Cleaning Solution
Company
DENTSPLY INTERNATIONAL INC.
Model
2221366FG
Catalog number
2221366FG
Device description
Pearson Quality Ultrasonic Cleaning Solution
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLGCleaner, ultrasonic, medical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6872221366FG1PrimaryHIBCC0
D6872221366FG0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on a medical device (e.g., surgical or dental instrument) and/or facility surface; it may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume473Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store below freezing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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