ENDOZIME SPONGE
GUDID 00810929010833
Enzymatic detergents used to clean medical instruments
Ruhof Corporation
Surgical instrument/endoscope cleaning utensil, single-use| Primary Device ID | 00810929010833 |
| NIH Device Record Key | ce5df04f-c28c-4247-b169-9fa0864a50fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOZIME SPONGE |
| Version Model Number | 345SPG |
| 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 | 00810929010826 [Primary] |
| GS1 | 00810929010833 [Package] Contains: 00810929010826 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
| 00810929011410 - ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) | 2025-07-21 brushes to clean medical instrumnets |
| 00810929011281 - ENDOZIME INSTRUSPONGE 1mm (RIGID) | 2025-07-18 brushes to clean medical instrument. |
| 00810929011298 - ENDOZIME INSTRUSPONGE 1.5mm (RIGID) | 2025-07-18 BRUSHES FOR CLEANING OF MEDICAL INSTRUMENTS |
| 00810929011519 - ENDOZIME INSTRUSPONGE 1.75mm (RIGID) | 2025-07-18 brushes to clean medical instrument |
| 00810929011311 - ENDOZIME INSTRUSPONGE 3mm (RIGID) | 2025-07-18 brushes to clean medical instruments |
| 00810929011526 - ENDOZIME INSTRUSPONGE 5mm (RIGID) | 2025-07-18 brushes to clean the medical instrumnets |
| 00810929011335 - ENDOZIME INSTRUSPONGE 7mm (RIGID) | 2025-07-18 brushes to clean medical instruments. |
| 00810929011342 - ENDOZIME INSTRUSPONGE 10mm (RIGID) | 2025-07-18 brushes to clean medical instruments |
Trademark Results [ENDOZIME SPONGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOZIME SPONGE 73814121 1586825 Live/Registered |
RUHOF CORPORATION, THE 1989-07-24 |
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