NEEDLE EP003997S BROCKEN 56CM STER 10L
NA - EP003997S
Device Description
A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.
Environmental Conditions
- 57.00
- -34.00
Device Sizes
- Length: 56.0 Centimeter
- Outer Diameter: 0.912 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DRC
Device Name: Trocar
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 870.1390
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 00721902015946
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