Smoke Evacuation Extension Tube 4"
Valleylab - SEA50595
Device Description
A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.
Environmental Conditions
- 90.00
- 15.00
- 40.00
- 10.00
- Keep Dry
- 90.00
- 15.00
- 60.00
- -30.00
Device Sizes
- Length: 10.16 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 Identifiers
Device Id: 30884521751136
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20884521751139
Package Quantity: 8
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10884521751132
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: 20884521751139
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521751132
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
