ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 10801902196603
• Version / Model: IPN920671
• Catalog Number: PT-12709-WC
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-15
• Public Version: 5
• Public Version Date: 2023-03-10
• Public Version Status: Update
• Public Device Record Key: 29756ebf-1c43-4d6b-892a-786bc3f2b5b5

Device Description

Arrow-Trerotola(TM) Over-The-Wire PTD(R) Kit (Percutaneous Thrombolytic Device)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXE	Catheter, embolectomy	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58172	Thrombectomy rotational catheter	A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801902196600	GS1	Case	1	In Commercial Distribution
Primary	10801902196603	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K011056	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: with relative humidity less than 65 percent. Avoid excessive cold below -20C (-4F) and excessive heat above 60C (140F).
• Type: Storage Environment Temperature
• Temperature Range: -25 – 10 Degrees Celsius