| Primary Device ID | 10858701006299 |
| NIH Device Record Key | 0039a88b-959a-4568-b9c0-555daae958b2 |
| Commercial Distribution Discontinuation | 2023-10-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | NOVADRAPE® |
| Version Model Number | ND8000 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10858701006299 [Primary] |
| GS1 | 20858701006296 [Package] Package: [10 Units] Discontinued: 2023-10-27 Not in Commercial Distribution |
| GS1 | 20858701006340 [Package] Package: [48 Units] Discontinued: 2023-10-27 Not in Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-10-30 |
| Device Publish Date | 2018-01-08 |
| 20858701006326 - SPY-PHI System | 2024-02-29 SPY-PHI drape |
| 10858701006220 - PINPOINT PAQ® | 2023-10-30 |
| 20858701006258 - SPY® | 2023-10-30 |
| 10858701006299 - NOVADRAPE® | 2023-10-30sterile drape |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NOVADRAPE 78699626 3236026 Live/Registered |
Novadaq Technologies Inc. 2005-08-24 |