FDA.report

TruePath™

Primary DI
08714729820291
Brand
TruePath™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939208001600
Device description
Extension Wire
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PDUCatheter for crossing total occlusions

Product Code Classifications

CodeDeviceSpecialtyClass
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08714729820291PackageGS15Not in Commercial Distribution
08714729839309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729820291087147298202918714729820291
08714729839309087147298393098714729839309

GMDN Terms

TermDefinition
Peripheral vascular guidewire extensionA long, thin, sterile wire designed to provide the necessary length to allow the exchange of a catheter, or other interventional device, while maintaining the intravascular position of the catheter guidewire during an interventional procedure in the peripheral vasculature. It is typically made of polymer-coated [e.g., polytetrafluoroethylene (PTFE)] stainless steel and is supplied with a connector (e.g., self-locking taper) to facilitate its joining to the proximal end of the in situ guidewire to create the extension (e.g., 150 mm). After the catheter exchange, the guidewire extension can be detached and the guidewire used as intended. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
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

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08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
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08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

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