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 |