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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00191506013813 [Primary] |
DQY | Catheter, percutaneous |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-20 |
Device Publish Date | 2021-09-10 |
00191506013813 | Access Sheath with Dilator |
00191506013806 | Access Sheath with Dilator |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WATCHMAN FXD CURVE 90623854 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2021-04-05 |