RotaWire™ and wireClip™ Torquer H802228240020

GUDID 08714729195566

Guidewire and Guidewire Manipulation Device

BOSTON SCIENTIFIC CORPORATION

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID08714729195566
NIH Device Record Key38ce36fb-ada3-47fa-b9a4-5fa61c0eca81
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotaWire™ and wireClip™ Torquer
Version Model NumberH802228240020
Catalog NumberH802228240020
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729185871 [Primary]
GS108714729195566 [Package]
Contains: 08714729185871
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCXCATHETER, CORONARY, ATHERECTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2026-03-31
Device Publish Date2014-09-24

On-Brand Devices [RotaWire™ and wireClip™ Torquer]

08714729195566Guidewire and Guidewire Manipulation Device
08714729195573Guidewire and Guidewire Manipulation Device

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