| Primary Device ID | 08714729994183 |
| NIH Device Record Key | 9e8a8821-3a56-41c4-ab1a-3c57a3398017 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpyGlass™ Discover |
| Version Model Number | M00546780 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729994183 [Primary] |
| FBN | Choledochoscope and accessories, flexible/rigid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-12 |
| Device Publish Date | 2020-06-04 |
| 08714729998754 | Digital Controller |
| 08714729998723 | Digital Controller |
| 08714729994183 | Digital Catheter |
| 00191506004774 | Jagwire™ Guidewire |
| 00191506004255 | SpyGlass™ Discover Retrieval Basket |
| 00191506005238 | Imager™ II IOC Catheter |
| 00191506013516 | Balloon Dilation Catheter |
| 00191506013509 | Balloon Dilation Catheter |
| 00191506013493 | Balloon Dilation Catheter |