| Primary Device ID | 00816634020303 |
| NIH Device Record Key | 075b710a-7567-474c-bf92-b7d5e600a877 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Model 1522 |
| Version Model Number | 1522 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00816634020303 [Primary] |
| 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 | 2024-12-27 |
| Device Publish Date | 2024-12-19 |
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| 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 |