- Physicians Office Resource

Tip Cleaner
Valleylab - E2401

Device Description

A wad designed to be used to periodically wipe clean (i.e., remove eschar build-up) a tip (e.g., an electrode or blade) used in an electrically-mediated surgical technique for cutting, coagulating, or cauterizing tissue. The device is typically abrasive on one side to facilitate cleaning, and adhesive on the other side so that it may be conveniently affixed to an easy access object in the operative arena (e.g., surgical drape, mayo stand). It may include a radiopaque thread making it visible on x-ray. This is a single-use device.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

75.00
0.00

Handling Environment Temperature - Degrees Fahrenheit

149.00
-29.00

Device Sizes

No Data Available

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: 10884524001821

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884524001828

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK

Device Id: 20884524001828

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: 30884524001825

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884524001821

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

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