RADIFOCUS GLIDEWIRE

RADIFOCUS GLIDEWIRE
GLIDEWIRE - EWSSA4535

A metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

• Length: 450 Centimeter
• Outer Diameter: 0.89 Millimeter
• Flexible Tip Length: 3cm

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: 34987350755897

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350755896

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Shelfbox

Device Id: 04987350755896

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

Device Id: 54987350755891

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 34987350755897

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton