Tigertriever 17 Revascularization Device

GUDID 07290015107273

The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath.

RAPID MEDICAL LTD

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Primary Device ID07290015107273
NIH Device Record Keye4a73de9-acfb-4c35-9391-e59648a4877c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTigertriever 17 Revascularization Device
Version Model NumberTRPP7166
Company DUNS532702946
Company NameRAPID MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Customer Support Contacts

Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com
Phone+972722503331
Emailorit@rapid-medical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature in its designated box

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015107273 [Primary]
GS117290015107270 [Package]
Package: [3 Units]
Discontinued: 2021-04-05
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-13
Device Publish Date2021-04-05

Devices Manufactured by RAPID MEDICAL LTD

17290015107300 - Tigertriever 13 Revascularization Device2022-08-05 The Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, niti
07290015107235 - Drivewire LR2021-09-03 The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire
07290015107242 - Drivewire SR2021-09-03 The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire
07290015107266 - Tigertriever Revascularization Device2021-04-13 The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol
07290015107273 - Tigertriever 17 Revascularization Device2021-04-13The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath.
07290015107273 - Tigertriever 17 Revascularization Device2021-04-13 The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol
07290015107136 - Comaneci2019-07-19 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

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