Firm Tip;Extended Working Channel;190 Catheter
Edge - SD190EWCTE-FT
Device Description
A sterile, flexible, single lumen tube designed to be used as a conduit to the lung(s) for the delivery of another device (e.g., an emphysematous lung sealant) during a bronchoscopic procedure. It is typically made of synthetic materials that resist kinking (may be capable of bending 135 degrees or more without kinking) and is advanced through the working channel of a bronchoscope to the treatment site by the operator, typically a pulmonologist or thoracic surgeon. The distal tip may be marked with a band to facilitate visualization by the operator during the procedure. This is a single-use device.
Environmental Conditions
- Keep dry
Device Sizes
- Length: 1069.5 Millimeter
- Outer Diameter: 2.68 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JAK
Device Name: System, X-Ray, Tomography, Computed
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: RA
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: 892.1750
Third Party Flag: Y
Medical Specialty: RA
Device IdentifiersDevice Id: 10884521581425
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