| Primary Device ID | 00817183020516 |
| NIH Device Record Key | 41508ed7-09ae-4b5b-8266-9136d388d221 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lithotripsy Probe 1.9FR 250cm French |
| Version Model Number | 9-195-25-F |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817183020516 [Primary] |
| FFK | Lithotriptor, Electro-Hydraulic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-18 |
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| 10817183020810 - PUREPNEUMO Tubing Set | 2024-07-17 Paired Insufflation and TAP Tubing |
| 00817183020769 - StimSite Signal Box | 2024-05-07 |
| 00817183020776 - StimSite Activation Card | 2023-11-29 Activation Card, StimSite, Single |
| 00817183020660 - NEBULAE SRS Tubing Set | 2023-02-22 |
| 00817183020684 - NEBULAE SRS Laparoscopic Surgical Pump | 2023-02-22 |
| 00817183020745 - Smith & Nephew Insufflator 500 | 2021-01-14 Insufflator, Laparoscopic, S&N 500 Service Replacement, 50LPM |