OptoWire

Basic Information

• Brand Name: OptoWire
• Primary DI: 07540184010325
• Version / Model: III
• Catalog Number: F1032
• Company Name: Opsens Inc
• Labeler DUNS: 253717946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-05
• Public Version: 3
• Public Version Date: 2020-10-27
• Public Version Status: Update
• Public Device Record Key: 5207d88e-79a1-4ce1-82d6-15bc92615091

Device Description

Pressure guidewire

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	870.2870	2
DQX	Wire, Guide, Catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15071	Catheter-tip transducer, pressure	A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.	No	Active
35094	Cardiac/peripheral vascular guidewire, single-use	A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540184010325	GS1
Package	07540184110322	GS1	carton box	5	In Commercial Distribution
Package	07540184210329	GS1	shipping box	20	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191907	000

Device Sizes

Type	Value	Unit	Text
Length	180	Centimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: – 54 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight.