CATHETER ES
EsoFLIP - ES-320
Device Description
A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.
Environmental Conditions
- 106.00
- 50.00
- 95.00
- 10.00
- 25.00
- 0.00
- 106.00
- 70.00
- 95.00
- 15.00
- 40.00
- 20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PIE
Device Name: Esophageal Dilator With Balloon And Electrode Sensors
Device Class: 2
Physical State: balloon with electrode sensors and software
Definition: To dilate esophageal strictures with a dilating balloon and electrode sensors.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: balloon with electrode sensors
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: esophagus
Regulation Number: 876.5980
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 20884521809441
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521809444
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
Device Id: 10884521809444
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