Drivewire LR

GUDID 07290015107235

The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

RAPID MEDICAL LTD

Cardiac/peripheral vascular guidewire, single-use

Primary Device ID	07290015107235
NIH Device Record Key	ce139084-ae15-43e3-96cb-7d31111a0847
Commercial Distribution Status	In Commercial Distribution
Brand Name	Drivewire LR
Version Model Number	DRLR7464
Company DUNS	532702946
Company Name	RAPID MEDICAL LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+972722503331
Email	orit@rapid-medical.com
Phone	+972722503331
Email	orit@rapid-medical.com
Phone	+972722503331
Email	orit@rapid-medical.com
Phone	+972722503331
Email	orit@rapid-medical.com
Phone	+972722503331
Email	orit@rapid-medical.com
Phone	+972722503331
Email	orit@rapid-medical.com
Phone	+972722503331
Email	orit@rapid-medical.com
Phone	+972722503331
Email	orit@rapid-medical.com
Phone	+972722503331
Email	orit@rapid-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015107235 [Primary]
GS1	17290015107232 [Package] Package: [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K200374

FDA Product Code

MOF	Guide, Wire, Catheter, Neurovasculature

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-09-03
Device Publish Date	2021-08-26

Devices Manufactured by RAPID MEDICAL LTD

17290015107300 - Tigertriever 13 Revascularization Device	2022-08-05 The Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, niti
07290015107235 - Drivewire LR	2021-09-03The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
07290015107235 - Drivewire LR	2021-09-03 The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire
07290015107242 - Drivewire SR	2021-09-03 The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire
07290015107266 - Tigertriever Revascularization Device	2021-04-13 The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol
07290015107273 - Tigertriever 17 Revascularization Device	2021-04-13 The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol
07290015107136 - Comaneci	2019-07-19 The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysm
07290015107143 - Comaneci Petit	2019-07-19 The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysm
27290015107154 - Comaneci 17	2019-07-19 The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysm