Single Use Biliary Balloon Dilator
Single Use Biliary Balloon Dilator - BD-210N-0440
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, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FGE
Device Name: Stents, Drains And Dilators For The Biliary Ducts
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 876.5010
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 14953170372275
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170372278
Package Quantity: 1
Package Discontinue Date: 8/19/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 04953170372278
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