ENDOZIME AW PLUS w/APA (4 Liter FB63)

GUDID 10810929040752

ENDOZIME AW PLUS w/APA (4 Liter FB63)

Ruhof Corporation

Medical device cleaning agent
Primary Device ID10810929040752
NIH Device Record Key2c11991f-333d-42da-98ab-d5dbc299479f
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOZIME AW PLUS w/APA (4 Liter FB63)
Version Model Number34521A-33
Company DUNS082779828
Company NameRuhof Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810929040755 [Primary]
GS110810929040752 [Package]
Contains: 00810929040755
Package: CASE [4 Units]
In Commercial Distribution

FDA Product Code

FLGCleaner, Ultrasonic, Medical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-24
Device Publish Date2025-06-16

On-Brand Devices [ENDOZIME AW PLUS w/APA (4 Liter FB63)]

00810929014602Enzymatic detergents used to clean medical instruments.
10810929040776Enzymatic detergents used to clean medical instruments.
10810929040752ENDOZIME AW PLUS w/APA (4 Liter FB63)

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