WATCHMAN TruSteer™ Access System M635TU90050

GUDID 00191506022310

Access Sheath with Dilator

BOSTON SCIENTIFIC CORPORATION

Cardiac occluder delivery kit
Primary Device ID00191506022310
NIH Device Record Keyf14241f7-02ce-4006-bca3-6eb8156c4275
Commercial Distribution StatusIn Commercial Distribution
Brand NameWATCHMAN TruSteer™ Access System
Version Model NumberM635TU90050
Catalog NumberM635TU90050
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Outer Diameter5.7 Millimeter
Lumen/Inner Diameter4.2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506022310 [Primary]

FDA Product Code

DQYCatheter, percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-23
Device Publish Date2024-02-15

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Trademark Results [WATCHMAN TruSteer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WATCHMAN TRUSTEER
WATCHMAN TRUSTEER
97479273 not registered Live/Pending
Boston Scientific Scimed, Inc.
2022-06-28
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