Laparoscopic Argon Blunt Needle Electrode Retractable
Valleylab - E3583-28
Device Description
An invasive, distal component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a single-use device.
Environmental Conditions
- 90.00
- 15.00
- 140.00
- -22.00
- Keep dry
- 90.00
- 15.00
- 104.00
- 50.00
Device Sizes
- Length: 28 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GEI
Device Name: Electrosurgical, Cutting & Coagulation & Accessories
Device Class: 2
Physical State: N/A
Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: SU
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: 878.4400
Third Party Flag: Y
Medical Specialty: SU
Device IdentifiersDevice Id: 30884521767953
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20884521767956
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10884521767959
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
Device Id: 20884521767956
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521767959
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK