FDA.reportPublic FDA data

SpyGlass Ocular

Primary DI
08714729773566
Brand
SpyGlass Ocular
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00546040
Device description
SpyGlass System Camera Ocular
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FDTduodenoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDTDuodenoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729773566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729773566087147297735668714729773566

GMDN Terms#

Term, Definition table
TermDefinition
ERCP catheter, non-balloon, non-electrical, reusableA non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a reusable device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170467370SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2026-03-06
14953170467377SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2026-03-06
04961333255801INSPIRAHOYA CORPORATIONFDT2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFDT2025-06-20
05707480157167Ambu® aScope™ Duodeno 2Ambu A/SFDT2025-03-29
04961333356355PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
04961333356331PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
05707480157143Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
05707480157136Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
04961333254910INSPIRAHOYA CORPORATIONFDT2023-12-01
04961333247974INSPIRAHOYA CORPORATIONFDT2023-09-16
14961333232960PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333232991PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333246233PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333084456PENTAXHOYA CORPORATIONFDT2023-07-31
04961333084470PENTAXHOYA CORPORATIONFDT2023-07-31
04961333232963PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333232994PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333246236PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04953170438066Air/water valveOLYMPUS MEDICAL SYSTEMS CORP.FDT2023-04-22
04953170438349CONNECTING TUBEOLYMPUS MEDICAL SYSTEMS CORP.FDT2023-04-19
04953170441271SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2022-06-01
14953170441278SINGLE USE DISTAL COVER MAJ-2315OLYMPUS MEDICAL SYSTEMS CORP.FDT2022-06-01
04953170452024EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VOLYMPUS MEDICAL SYSTEMS CORP.FDT2022-06-01
05707480157402aScope™ DuodenoAmbu A/SFDT2022-04-19
05707480157426aScope™ DuodenoAmbu A/SFDT2022-04-19
04961333246632PENTAX MedicalHOYA CORPORATIONFDT2022-02-02
04961333246168N/AHOYA CORPORATIONFDT2022-02-02
04953170063749EYEPIECE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDT2021-12-20
04953170064012LIGHTGUIDE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDT2021-12-20