ENDOZIME BIO-CLEAN (10 Liter SB63)

GUDID 00810929016897

Enzymatic detergents used to clean medical instruments.

Ruhof Corporation

Medical device cleaning agent

• Primary Device ID: 00810929016897
• NIH Device Record Key: d15e2e71-20d9-4412-b762-52edd29db26d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOZIME BIO-CLEAN (10 Liter SB63)
• Version Model Number: 34524-34
• Company DUNS: 082779828
• Company Name: Ruhof Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810929016880 [Primary]
GS1	00810929016897 [Package]; Contains: 00810929016880; Package: CASE [2 Units]; In Commercial Distribution

FDA Product Code

• FLG: Cleaner, Ultrasonic, Medical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-24
• Device Publish Date: 2025-06-16

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.