Straight Extension

Straight Extension
Valleylab - E1504

A long, thin electrical conductor intended to extend the length of a monopolar electrosurgical electrode during an open surgical procedure. The electrode is fixed to the distal end of the device and the proximal end is attached to an electrosurgical handpiece. This is a reusable device intended to be sterilized prior to use.

• Length: 34.3 Centimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

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 Id: 10884524001333

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