Temperature Monitor
HET - 180-1007
Device Description
A device designed to detect an interruption in dispersive cable continuity between an electrosurgical system generator and the dispersive (return) electrode, potentially due to current leakage. This device functions as a special form of patient circuit safety monitor and will give an alarm when a pre-set safety limit is exceeded. This is a stand-alone device; its function is typically built into modern electrosurgical units.
Environmental Conditions
- Keep Dry
- 149.00
- 29.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Dry Heat Sterilization
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: 10884521511156
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
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