| Primary Device ID | 00816634020105 |
| NIH Device Record Key | 415146e3-1372-44da-95cc-3f40fac77467 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sanizyme 30-Gallons |
| Version Model Number | 92-0015 |
| 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 | 00816634020105 [Primary] |
| GS1 | 10816634020102 [Package] Package: Pallet [1 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 |
| 00816634020396 - Xi Adapter | 2025-07-17 X/Xi 1101 Adapters - 6/PK X/Xi Triton Adapters - 10/PK |
| 00816634020464 - Xi Adapter R2 | 2025-07-17 |
| 00816634020488 - D5 Adapter | 2025-07-17 |
| 00816634020440 - SP Adapter | 2025-07-17 SP Adapter - 8/pk |
| 10816634020263 - 1101 - Xi RACS tray with adapters (6) | 2025-05-15 Xi RACS tray with adapters (6) for Model 1101 |
| 00816634020358 - Hospital wire mesh tray | 2025-04-04 Hospital wire mesh tray |
| 20816634020079 - Sanizyme 2.5-Gallon | 2025-03-12 Sanizyme 2.5-Gallon, 2 pack |
| 10816634020096 - Sanizyme 15-Gallons | 2025-03-12 Sanizyme 15-Gallons |