| Primary Device ID | 20858701006210 |
| NIH Device Record Key | be3abd73-bff6-4313-ab5f-63d0f229a02c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPY |
| Version Model Number | SK6000 |
| Catalog Number | SK6000 |
| Company DUNS | 243730939 |
| Company Name | Novadaq Technologies 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 | true |
| 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(604)232-9861 |
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| Phone | +1(604)232-9861 |
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| Phone | +1(604)232-9861 |
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| Phone | +1(604)232-9861 |
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| Phone | +1(604)232-9861 |
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| Phone | +1(604)232-9861 |
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| Phone | +1(604)232-9861 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10858701006213 [Primary] |
| GS1 | 20858701006210 [Package] Contains: 10858701006213 Package: pack [6 Units] In Commercial Distribution |
| IZI | System, x-ray, angiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-29 |
| Device Publish Date | 2020-09-21 |
| 20858701006326 - SPY-PHI System | 2024-02-29 SPY-PHI drape |
| 10858701006220 - PINPOINT PAQ® | 2023-10-30 |
| 20858701006258 - SPY® | 2023-10-30 |
| 10858701006299 - NOVADRAPE® | 2023-10-30 sterile drape |
| 10858701006176 - PINPOINT PAQ® | 2020-11-06 |
| 10858701006237 - PINPOINT PAQ® | 2020-11-06 |
| 10858701006244 - LUNA PAQ® | 2020-11-06 |
| 20858701006265 - SPY PAQ® | 2020-11-06 |