RADIFOCUS GLIDEWIRE

RADIFOCUS GLIDEWIRE
GLIDEWIRE - EWS4520

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.

• Length: 450 Centimeter
• Flexible Tip Length: 3cm
• Outer Diameter: 0.51 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GCJ

Device Name: Laparoscope, General & Plastic Surgery

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: OCY

Device Name: Endoscopic Guidewire, Gastroenterology-Urology

Device Class: 2

Physical State: metal guidewire with or without polymer coating, and associated guidewire accessories

Definition: To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: placed through working channel of endoscope

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various in GI and GU tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: DQX

Device Name: Wire, Guide, Catheter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1330

Third Party Flag: Y

Medical Specialty: CV

Device Id: 54987350756133

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 34987350756139

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 34987350756139

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350756138

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Shelfbox

Device Id: 04987350756138

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A