| Primary Device ID | 00810929011281 |
| NIH Device Record Key | e62af66c-dfd6-4821-85a1-ae3eed18a287 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOZIME INSTRUSPONGE 1mm (RIGID) |
| Version Model Number | 345ESS1R |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810929010017 [Primary] |
| GS1 | 00810929011281 [Package] Contains: 00810929010017 Package: case [100 Units] In Commercial Distribution |
| FLG | Cleaner, Ultrasonic, Medical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-18 |
| Device Publish Date | 2025-07-10 |
| 10810929045627 - ENDOZIME BIO-CLEAN NP(4 Liter RB38) | 2025-09-30 Enzymatic detergents used to clean medical instruments. |
| 00810929011410 - ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) | 2025-07-21 brushes to clean medical instrumnets |
| 00810929011281 - ENDOZIME INSTRUSPONGE 1mm (RIGID) | 2025-07-18brushes to clean medical instrument. |
| 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. |