PROWLER

Basic Information

• Brand Name: PROWLER
• Primary DI: 00878528009078
• Version / Model: MST270000-00
• Catalog Number: MST27000000
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 5
• Public Version Date: 2023-11-30
• Public Version Status: Update
• Public Device Record Key: 6ff1d870-796e-46da-9fd3-b04f06804ee2
• Distribution End Date: 2020-03-31

Device Description

PROWLER microcatheter PROWLER 27 Microcatheter .0270 Inch I.D. - 150cm - Straight 90 cm 3 cm 3.0 F (1.01 mm) 2.6 F (0.87 mm) .0270 Inch (0.69 mm) Contents: 1 Microcatheter and 1 Shaping Mandrel

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10691	Vascular microcatheter	A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00878528009078	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092702	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 131 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: High: 55 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 55 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 131 Degrees Fahrenheit