ENDOZIME (5GL/20L RP)

GUDID 00810929013315

Enzymatic detergents used to clean medical instruments.

Ruhof Corporation

Medical device cleaning agent
Primary Device ID00810929013315
NIH Device Record Key7c4f9607-9db5-4573-a41e-a8b83229cf51
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOZIME (5GL/20L RP)
Version Model Number34509-37
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-Counterfalse

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
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
GS100810929013315 [Primary]

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 Date2025-06-19
Device Publish Date2025-06-11

Devices Manufactured by Ruhof Corporation

00810929010390 - ENDOZIME AW PLUS (4 Liter RB38)2025-06-20 Enzymatic detergents used to clean medical instruments.
00810929010659 - ENDOZIME (16.9oz/500ml bottle)2025-06-20 Enzymatic detergents used to clean medical instruments.
00810929010734 - ENDOZIME AW PLUS (8.45oz/250ml bottle)2025-06-20 Enzymatic detergents used to clean medical instruments.
00810929010758 - ENDOZIME AW PLUS (16.9oz/500ml bottle)2025-06-20 Enzymatic detergents used to clean medical instruments.
10810929012292 - ENDOZIME AW NP (1 Gallon RB38)2025-06-20 Enzymatic detergents used to clean medical instruments.
00810929012752 - ENDOZIME AW PLUS (4 Liter RB53)2025-06-20 Enzymatic detergents used to clean medical instruments.
00810929013186 - ENDOZIME AW PLUS WITH IONS (10 Liter SB63)2025-06-20 Enzymatic detergents used to clean medical instruments.
00810929013209 - ENDOZIME AW PLUS NP (4 Liter RB38)2025-06-20 Enzymatic detergents used to clean medical instruments.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.