Insufflation Needle
Surgineedle - 172016
Device Description
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.
Environmental Conditions
- 130.00
- N/A
Device Sizes
- length,long,N/A;
- Length: 150 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 10884521080812
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20884521080819
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 20884521080819
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