| Primary Device ID | 00817183020554 |
| NIH Device Record Key | ff16d91f-7332-465a-8645-8a2d0585ba9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Autolith Touch |
| Version Model Number | M0054668H0 |
| Company DUNS | 627969264 |
| Company Name | NORTHGATE TECHNOLOGIES INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817183020554 [Primary] |
| FFK | Lithotriptor, Electro-Hydraulic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-10 |
| 00817183020561 | Lithotripter, Biliary, BSC, Zero Cost Refurbished |
| 00817183020554 | Lithotripter, Biliary, BSC, Hospital Owned |
| 00817183020547 | Lithotripter, Biliary, BSC, Loaner |
| 00817183020530 | Lithotripter, Biliary, BSC, Demo |
| 00817183020523 | Lithotripter, Biliary, BSC, Refurbished |
| 00817183020493 | Lithotripter, Biliary, BSC |
| 00817183020004 | Lithotripter |