FDA.reportPublic FDA data

SpyGlass™ Discover

Primary DI
00191506013509
Brand
SpyGlass™ Discover
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00543010
Catalog number
M00543010
Device description
Balloon Dilation Catheter
Published
2022-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCABiliary Catheter for stone removal that may also allow for irrigation and contrast injection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506013509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506013509001915060135091915060135090191506013509

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheterA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter7Millimeter
Balloon Length40Millimeter
Length40Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970057571027Stone Extraction BalloonJiangsu Vedkang Medical Science and Technology Co.,Ltd.GCA2026-04-14
06948318963102AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
06948318963119AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
04711182608309Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
04711182608316Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608306Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608313Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
06959664910702NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910719NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910740NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910757NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910709NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910716NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910747NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910754NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
00191506013493SpyGlass™ DiscoverBOSTON SCIENTIFIC CORPORATIONGCA2022-06-03
00191506013516SpyGlass™ DiscoverBOSTON SCIENTIFIC CORPORATIONGCA2022-06-03
10195594641436CARDINAL HEALTHCardinal Health 200, LLCGCA2022-04-12
50195594641434CARDINAL HEALTHCardinal Health 200, LLCGCA2022-04-12
10827002588032AdvanceCOOK INCORPORATEDGCA2021-02-09
10827002588049AdvanceCOOK INCORPORATEDGCA2021-02-09
00690103205114FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205121FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205138FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205119FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205126FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205133FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00816349011696TaxiLake Region MedicalGCA2018-11-27
04711182607548Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2017-08-15
00816349011436AnchorwireLake Region MedicalGCA2017-01-25