Insufflation Needle

Insufflation Needle
Surgineedle - 172015

A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.

• Length: 120 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FHO

Device Name: Pneumoperitoneum Needle

Device Class: 2

Physical State: May include: needle, stylet, housing handle.

Definition: For establishment of a pneumoperitoneum in abdomen.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Instrument inserted into abdomen and gasses or fluids are passed into needle to inflate the abdominal cavity.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: abdominal cavity

Regulation Number: 876.1500

Third Party Flag: Y

Medical Specialty: GU

Device Id: 20884521080802

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521080805

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521080805

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