FDA.reportPublic FDA data

Sensor

Primary DI
08714729376378
Brand
Sensor
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0066703090
Device description
Nitinol Wire with Hydrophilic Tip
Published
2016-09-24
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
EZBSTYLET FOR CATHETER, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZBStylet For Catheter, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729257318PackageGS15In Commercial Distribution
08714729376378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729257318087147292573188714729257318
08714729376378087147293763788714729376378

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421267MillenniumAvalign Technologies, Inc.EZB2026-05-04
00190776415419MillenniumAvalign Technologies, Inc.EZB2026-01-27
00190776389789MillenniumAvalign Technologies, Inc.EZB2024-11-18
00190776307356MillenniumAvalign Technologies, Inc.EZB2023-11-17
00190776303020MillenniumAvalign Technologies, Inc.EZB2023-11-16
00190776303341MillenniumAvalign Technologies, Inc.EZB2023-11-16
00190776302016MillenniumAvalign Technologies, Inc.EZB2023-11-15
00810143901191SURGIPROSSurgipros, LLCEZB2023-09-08
00190776350710MillenniumAvalign Technologies, Inc.EZB2023-01-10
00190776296933MillenniumAvalign Technologies, Inc.EZB2022-12-12
00190776163730MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163747MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163754MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163761MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163778MillenniumAvalign Technologies, Inc.EZB2021-11-01
00827002448469Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00827002448483Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00827002448490Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00827002448551Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00801741051449NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051456NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051463NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051470NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051487NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051494NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051500NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051517NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051524NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051531NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
10801741051446NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23