| Primary Device ID | 20816634020079 |
| NIH Device Record Key | beb5b078-bd40-4750-bc48-3811631c26f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sanizyme 2.5-Gallon |
| Version Model Number | 92-0000 |
| Company DUNS | 010043227 |
| Company Name | Ultra Clean Systems, Inc. |
| 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 | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816634020075 [Primary] |
| GS1 | 10816634020072 [Package] Package: Pallet [16 Units] In Commercial Distribution |
| GS1 | 20816634020079 [Package] Contains: 00816634020075 Package: Case [2 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 | 2025-03-12 |
| Device Publish Date | 2025-03-04 |
| 00816634020358 - Hospital wire mesh tray | 2025-04-04 Hospital wire mesh tray |
| 20816634020079 - Sanizyme 2.5-Gallon | 2025-03-12Sanizyme 2.5-Gallon, 2 pack |
| 20816634020079 - Sanizyme 2.5-Gallon | 2025-03-12 Sanizyme 2.5-Gallon, 2 pack |
| 10816634020096 - Sanizyme 15-Gallons | 2025-03-12 Sanizyme 15-Gallons |
| 00816634020105 - Sanizyme 30-Gallons | 2025-03-12 Sanizyme 30-Gallons |
| 00816634020310 - Sanizyme 5-Gallon | 2025-03-12 Sanizyme 5-Gallon |
| 00816634020372 - Sanizyme 1-Gallon | 2025-03-12 Sanizyme 1-Gallon, 4 pack |
| 00816634020136 - 1100 - Lumen Tray with Accessory Kit | 2025-01-21 Model 1100 - Lumen Tray with Accessory Kit |
| 00816634020143 - 1150 - Lumen Tray with Accessory Kit | 2025-01-21 Model 1150 - Lumen tray with Accessory kit |