RADIFOCUS GLIDEWIRE
GLIDEWIRE - EWS9035
Device Description
A sterile 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.
Environmental Conditions
- Fragile.Keep away from rain. Keep away from sunlight.
Device Sizes
- Flexible Tip Length: 3cm
- Length: 260 Centimeter
- Outer Diameter: 0.89 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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: 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: 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 IdentifiersDevice Id: 34987350755712
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04987350755711
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Shelfbox
Device Id: 04987350755711
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: 54987350755716
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 34987350755712
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton