| Primary Device ID | 00817183020479 |
| NIH Device Record Key | 84a87525-c466-4a56-8e78-7c8cd0c9cd85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Foot Switch, Autolith Touch |
| Version Model Number | M00546760 |
| Catalog Number | 72-00323-0 |
| Company DUNS | 627969264 |
| Company Name | NORTHGATE TECHNOLOGIES INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Serial Number | false |
| 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 | 00817183020479 [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 | 2017-10-23 |
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