- Physicians Office Resource

RADIFOCUS GLIDEWIRE
GLIDEWIRE - GR3518

Device Description

A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Fragile.Keep away from rain. Keep away from sunlight.

Device Sizes

Length: 150 Centimeter

Flexible Tip Length: 1cm

Outer Diameter: 0.89 Millimeter

Length: 150 Centimeter
Flexible Tip Length: 1cm
Outer Diameter: 0.89 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 54987350778470

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 34987350778476

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 34987350778476

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350778475

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Shelfbox

Device Id: 04987350778475

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

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