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 Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use 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