SpyGlass™ Discover M00543040

GUDID 00191506013493

Balloon Dilation Catheter

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter
Primary Device ID00191506013493
NIH Device Record Key41a4f9df-e57f-4878-9718-5f6d1815b2f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpyGlass™ Discover
Version Model NumberM00543040
Catalog NumberM00543040
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

Balloon Length40 Millimeter
Balloon Diameter8 Millimeter
Length40 Centimeter
Balloon Length40 Millimeter
Balloon Diameter8 Millimeter
Length40 Centimeter
Balloon Length40 Millimeter
Balloon Diameter8 Millimeter
Length40 Centimeter
Balloon Length40 Millimeter
Balloon Diameter8 Millimeter
Length40 Centimeter
Balloon Length40 Millimeter
Balloon Diameter8 Millimeter
Length40 Centimeter
Balloon Length40 Millimeter
Balloon Diameter8 Millimeter
Length40 Centimeter
Balloon Length40 Millimeter
Balloon Diameter8 Millimeter
Length40 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506013493 [Primary]

FDA Product Code

GCABiliary Catheter for stone removal that may also allow for irrigation and contrast injection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-13
Device Publish Date2022-06-03

On-Brand Devices [SpyGlass™ Discover]

08714729998754Digital Controller
08714729998723Digital Controller
08714729994183Digital Catheter
00191506004774Jagwire™ Guidewire
00191506004255SpyGlass™ Discover Retrieval Basket
00191506005238Imager™ II IOC Catheter
00191506013516Balloon Dilation Catheter
00191506013509Balloon Dilation Catheter
00191506013493Balloon Dilation Catheter

Trademark Results [SpyGlass]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPYGLASS
SPYGLASS
98176310 not registered Live/Pending
Saronic Technologies, Inc.
2023-09-12
SPYGLASS
SPYGLASS
98176307 not registered Live/Pending
Saronic Technologies, Inc.
2023-09-12
SPYGLASS
SPYGLASS
97613210 not registered Live/Pending
Quisitive, LLC
2022-09-29
SPYGLASS
SPYGLASS
97610037 not registered Live/Pending
Sidebotham Group LLC
2022-09-28
SPYGLASS
SPYGLASS
97474746 not registered Live/Pending
Halliburton Energy Services, Inc.
2022-06-24
SPYGLASS
SPYGLASS
90872790 not registered Live/Pending
Artistree Host, LLC
2021-08-09
SPYGLASS
SPYGLASS
90456041 not registered Live/Pending
Grayscale Brewing, LLC
2021-01-08
SPYGLASS
SPYGLASS
88866421 not registered Live/Pending
Numerica Corporation
2020-04-09
SPYGLASS
SPYGLASS
88749766 not registered Live/Pending
BGE Inc.
2020-01-07
SPYGLASS
SPYGLASS
87919551 not registered Dead/Abandoned
Spyglass Holdings, LLC
2018-05-14
SPYGLASS
SPYGLASS
87866774 not registered Dead/Abandoned
Numerica Corporation
2018-04-06
SPYGLASS
SPYGLASS
87802361 5672864 Live/Registered
Mariner, LLC
2018-02-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.