FDA.reportPublic FDA data

HydroSteer™

Primary DI
05414734055154
Brand
HydroSteer™
Company
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Model
405077
Catalog number
405077
Device description
Guidewires
Published
2015-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWIRE, GUIDE, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15414734055151PackageGS15Not in Commercial Distribution
05414734055154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473405515115414734055151
05414734055154054147340551545414734055154

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length260Centimeter
Outer Diameter0.038Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DARK, DRY PLACE.

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
040960379
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734202398Livewire™4016524016522015-02-06
05414734001052Pacel™4017664017662015-07-31
05414734001076Pacel™4017674017672015-07-31
05414734001090Pacel™4017684017682015-07-31
05414734001113Pacel™4017704017702015-07-31
05414734001137Pacel™4017714017712015-07-31
05414734001151Pacel™4017724017722015-07-31
05414734001175Pacel™4017734017732015-07-31
05414734001199Pacel™4017744017742015-07-31
05414734001212Pacel™4017754017752015-07-31
05414734001236Pacel™4017764017762015-07-31
05414734026512Pacel™4017654017652015-07-31
05414734027281Pacel™4017694017692015-07-31
05414734001045Pacel™4017624017622016-01-28
05414734007856Pacel™4017634017632016-01-28
05414734021906Pacel™4017614017612016-01-28
05414734022521Pacel™4017644017642016-01-28
05414734205153BRK™G407211G4072112015-11-13
05414734202183Livewire™4015754015752015-02-06
05414734202244Livewire™4015814015812015-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
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07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
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07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
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07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
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