| Primary Device ID | H668001221 |
| NIH Device Record Key | f00212b8-af50-40ae-a049-75bf4889516b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optimize |
| Version Model Number | 00122 |
| Catalog Number | 00122 |
| Company DUNS | 073503117 |
| Company Name | Keystone Industries |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com |
| Total Volume | 128 Fluid Ounce |
| Total Volume | 3.78 Liter |
| Total Volume | 128 Fluid Ounce |
| Total Volume | 3.78 Liter |
| Total Volume | 128 Fluid Ounce |
| Total Volume | 3.78 Liter |
| Total Volume | 128 Fluid Ounce |
| Total Volume | 3.78 Liter |
| Total Volume | 128 Fluid Ounce |
| Total Volume | 3.78 Liter |
| Total Volume | 128 Fluid Ounce |
| Total Volume | 3.78 Liter |
| Total Volume | 128 Fluid Ounce |
| Total Volume | 3.78 Liter |
| Total Volume | 128 Fluid Ounce |
| Total Volume | 3.78 Liter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H668001221 [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 | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| H668001631 | Refresh Ultrasonic Cleaning Solution Concentrate |
| H668001581 | General Purpose Ultrasonic Powder Concentrate |
| H668001571 | UltrasonicTartar and Stain Powder |
| H668001391 | UltrasonicTartar & Stain Liquid |
| H668001221 | General Purpose Ultrasonic Liquid Concentrate |