ENDOZIME SLR (OLESTRAZIME) SPONGE

GUDID 00810929010857

Enzymatic detergents used to clean medical instruments.

Ruhof Corporation

Surgical instrument/endoscope cleaning utensil, single-use

• Primary Device ID: 00810929010857
• NIH Device Record Key: ffb5e455-d743-4591-9992-965cc9092bda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOZIME SLR (OLESTRAZIME) SPONGE
• Version Model Number: 345OSP
• 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
• 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
• 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	00810929010840 [Primary]
GS1	00810929010857 [Package]; Contains: 00810929010840; Package: case [100 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: 2025-07-11
• Device Publish Date: 2025-07-03

Devices Manufactured by Ruhof Corporation

• 00810929011380 - ENDOZIME INSTRUSPONGE 1.5mm (FLEXIBLE): 2025-07-15 Enzymatic detergents used to clean medical instruments.
• 00810929016804 - SCOPEVALET ENDO BRUSH (2-4mm): 2025-07-15 Brushes for cleaning of medical instruments.
• 00810929016835 - SCOPEVALET ENDO BRUSH (4-5mm): 2025-07-15 Brushes to clean medical instrument
• 00810929018471 - SCOPEVALET ENDO BRUSH & DUAL END VALVE BRUSH 2mm-4mm: 2025-07-15 brushes to clean medical instrument.
• 00810929018495 - SCOPEVALET ENDO BRUSH & DUAL END VALVE BRUSH 4mm-5mm: 2025-07-15 brushes for cleaning of medical instruments
• 00810929010833 - ENDOZIME SPONGE: 2025-07-11 Enzymatic detergents used to clean medical instruments
• 00810929010857 - ENDOZIME SLR (OLESTRAZIME) SPONGE: 2025-07-11Enzymatic detergents used to clean medical instruments.
• 00810929010857 - ENDOZIME SLR (OLESTRAZIME) SPONGE: 2025-07-11 Enzymatic detergents used to clean medical instruments.
• 00810929011908 - ENDOZIME SLR BEDSIDE KIT 250ml CONT.: 2025-07-11 Enzymatic detergents used to clean medical instruments.