SpyGlass™ Discover M00543000
GUDID 00191506013516
Balloon Dilation Catheter
BOSTON SCIENTIFIC CORPORATION
Gastrointestinal/biliary dilation balloon catheter| Primary Device ID | 00191506013516 |
| NIH Device Record Key | 4c281bde-ec99-4298-ab9a-54d6566aa36a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpyGlass™ Discover |
| Version Model Number | M00543000 |
| Catalog Number | M00543000 |
| 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 Dimensions
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Length | 40 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506013516 [Primary] |
FDA Product Code
| GCA | Biliary Catheter for stone removal that may also allow for irrigation and contrast injection |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-13 |
| Device Publish Date | 2022-06-03 |
On-Brand Devices [SpyGlass™ Discover]
| 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 |
Trademark Results [SpyGlass]
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