- Physicians Office Resource

NEEDLE EP003994S BROCKENBROUGH ADULT
NA - EP003994S

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

Storage Environment Temperature - Degrees Celsius

57.00
-34.00

Device Sizes

Length: 71.0 Centimeter

Outer Diameter: 1.02 Millimeter

Length: 71.0 Centimeter
Outer Diameter: 1.02 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 Identifiers

Device Id: 00613994663146

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

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