WATCHMAN FXD Curve™ Access System M635TU80020
GUDID 00191506013813
Access Sheath with Dilator
BOSTON SCIENTIFIC CORPORATION
Cardiac occluder delivery kit| Primary Device ID | 00191506013813 |
| NIH Device Record Key | b7e92011-d3f2-446a-98a0-7ed245a959f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WATCHMAN FXD Curve™ Access System |
| Version Model Number | M635TU80020 |
| Catalog Number | M635TU80020 |
| 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 | 75 Centimeter |
| Outer Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 75 Centimeter |
| Outer Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506013813 [Primary] |
FDA Product Code
| DQY | Catheter, percutaneous |
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 | 2021-09-20 |
| Device Publish Date | 2021-09-10 |
On-Brand Devices [WATCHMAN FXD Curve™ Access System]
| 00191506013813 | Access Sheath with Dilator |
| 00191506013806 | Access Sheath with Dilator |
Trademark Results [WATCHMAN FXD Curve]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WATCHMAN FXD CURVE 90623854 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2021-04-05 |
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