FDA.reportPublic FDA data

Dreamwire

Primary DI
08714729777823
Brand
Dreamwire
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00556130
Device description
High Performance Guidewire
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
08714729777823PackageGS12In Commercial Distribution
08714729779575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729777823087147297778238714729777823
08714729779575087147297795758714729779575

GMDN Terms#

Term, Definition table
TermDefinition
Tracheobronchial guidewireA sterile metal wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., bronchoscope, catheter] exclusively within the tracheobronchial tree. 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431150MillenniumAvalign Technologies, Inc.EZB2026-09-21
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