FDA.reportPublic FDA data

Sensor

Primary DI
08714729376385
Brand
Sensor
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0066703120
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
08714729257349PackageGS15In Commercial Distribution
08714729376385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729257349087147292573498714729257349
08714729376385087147293763858714729376385

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
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16
00191506019648Rubicon™ ControlH749394321813A0H749394321813A02024-02-16
00191506019662Rubicon™ ControlH749394321815A0H749394321815A02024-02-16
00191506019686Rubicon™ ControlH749394321815S0H749394321815S02024-02-16
00191506019709Rubicon™ ControlH749394323506A0H749394323506A02024-02-16
00191506019723Rubicon™ ControlH749394323506B0H749394323506B02024-02-16
00191506019747Rubicon™ ControlH749394323509A0H749394323509A02024-02-16
00191506019761Rubicon™ ControlH749394323509B0H749394323509B02024-02-16

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