OLYMPUS ENDOSCOPY KIT VII

GUDID 10810929045481

OLYMPUS ENDOSCOPY KIT VII

Ruhof Corporation

Endoscopy preparation kit

• Primary Device ID: 10810929045481
• NIH Device Record Key: dffd6f6b-4856-4d82-9a7a-2dd61084c655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OLYMPUS ENDOSCOPY KIT VII
• Version Model Number: 345CKETG
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810929045484 [Primary]
GS1	10810929045481 [Package]; Contains: 00810929045484; Package: CASE [12 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: 2025-07-02
• Device Publish Date: 2025-06-24

Devices Manufactured by Ruhof Corporation

• 00810929010192 - PREPZYME (22 ounce/650ml with foam sprayer): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929011151 - PREPZYME (8.45oz/250ml with dropper): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929013605 - PREPZYME (4 Liter RB38): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016200 - PREMIX CONCENTRADO(4 Liter FB63): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016262 - PREPZYME (3oz/90ml bottle): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016323 - PREPZYME (10 Liter SB63): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016330 - PREPZYME (5GL/20L RP): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016354 - PREPZYME (60 Liter Drum): 2025-07-03 Enzymatic detergents used to clean medical instruments.