FDA.reportPublic FDA data

Drivewire 24 Guidewire

Primary DI
07290015107358
Brand
Drivewire 24 Guidewire
Company
RAPID MEDICAL LTD
Model
DRPP2411
Device description
The Drivewire 24 Guidewire is a 0.024” steerable guidewire with a deflectable tip controlled via a proximal handle. The distal section is radiopaque to aid fluoroscopic visualization and has a hydrophilic polymer coating. The guidewire packaging includes a torque device.
Published
2025-04-06
Public version status
New
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233791000Drivewire 24 GuidewireRapid-Medical , Ltd.2024-07-11MOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015107358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015107358072900151073587290015107358

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature in its designated box

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972547954003ina.gutman@rapid-medical.com

Regulatory Flags#

DUNS number
532702946
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015107372BraidE Embolization Assist DeviceBRPP70042026-04-14
07290015107303Tigertriever 13 Revascularization DeviceTRPP7144TRPP71442022-07-28
07290015107266Tigertriever Revascularization DeviceTRPP7155TRPP71552021-04-05
07290015107273Tigertriever 17 Revascularization DeviceTRPP71662021-04-05
07290015107341Tigertriever 25 Revascularization DeviceTRPP71252026-03-16
07290015107402Tigertriever 17 Ultra Revascularization DeviceTRPP72662025-11-17
17290015107300Tigertriever 13 Revascularization DeviceTRPP7144TRPP71442022-07-28
07290015107235Drivewire LRDRLR74642021-08-26
07290015107242Drivewire SRDRSR74632021-08-26
07290015107150Comaneci 17 ANPP71992019-05-17
07290015107136ComaneciANPP71772019-05-17
07290015107143Comaneci Petit ANPP71882019-05-17
27290015107154Comaneci 17 ANPP71992019-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
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10193489078022NAMICMEDLINE INDUSTRIES, INC.DQX2022-02-24
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07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
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