ENDOZIME AW PLUS w/APA (8.45oz/250ml bottle)

GUDID 10810929040783

Enzymatic detergents used to clean medical instruments.

Ruhof Corporation

Medical device cleaning agent
Primary Device ID10810929040783
NIH Device Record Key3910d473-a959-4357-8b03-67bce0d7cf3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOZIME AW PLUS w/APA (8.45oz/250ml bottle)
Version Model Number34521A-10
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 Numbertrue
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810929040786 [Primary]
GS110810929040783 [Package]
Contains: 00810929040786
Package: CASE [20 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 Date2025-06-23
Device Publish Date2025-06-13

Devices Manufactured by Ruhof Corporation

10810929012339 - ENDOZIME BIO-CLEAN (1 Gallon RB38)2025-06-24 Enzymatic detergents used to clean medical instruments.
00810929012929 - ENDOZIME BIO-CLEAN (16.9oz/500ml bottle)2025-06-24 Enzymatic detergents used to clean medical instruments.
00810929012943 - ENDOZIME BIO-CLEAN (1 Liter bottle)2025-06-24 Enzymatic detergents used to clean medical instruments.
00810929012967 - ENDOZIME BIO-CLEAN (4 Liter RB38)2025-06-24 Enzymatic detergents used to clean medical instruments.
00810929012981 - ENDOZIME BB (1 Liter bottle)2025-06-24 Enzymatic detergents used to clean medical instruments.
00810929012998 - ENDOZIME BB (4 Liter RB38)2025-06-24 Enzymatic detergents used to clean medical instruments.
00810929013759 - ENDOZIME BIO-CLEAN (5GL/20L RP)2025-06-24 Enzymatic detergents used to clean medical instruments.
00810929013773 - ENDOZIME BIO-CLEAN (15 GALLON DRUM)2025-06-24 Enzymatic detergents used to clean medical instruments.

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