Tigertriever 13 Revascularization Device TRPP7144

GUDID 17290015107300

The Tigertriever 13 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. The Tigertriever 13 Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.

RAPID MEDICAL LTD

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter
Primary Device ID17290015107300
NIH Device Record Key0f3c3c8c-8d97-40a8-9693-ee4cfa3337d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTigertriever 13 Revascularization Device
Version Model NumberTRPP7144
Catalog NumberTRPP7144
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015107303 [Primary]
GS117290015107300 [Package]
Contains: 07290015107303
Package: [3 Units]
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 Date2022-08-05
Device Publish Date2022-07-28

Devices Manufactured by RAPID MEDICAL LTD

17290015107300 - Tigertriever 13 Revascularization Device2022-08-05The Tigertriever 13 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. The Tigertriever 13 Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
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 Device2021-04-13 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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