Modified Cournand 2
NA - 0910182000
Device Description
An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Distal Length: 5.4 Centimeter
- Needle Gauge: 18.0 Gauge
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DYB
Device Name: Introducer, 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: 870.1340
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 37613252722916
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613252722915
Package Quantity: 20
Package Discontinue Date: 2/2/2017 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: pack
Device Id: 07613252722915
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