- Physicians Office Resource

Transducer Cover
McKesson - 16-1401

Device Description

A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: KKX

Device Name: Drape, Surgical, Antimicrobial

Device Class: 2

Physical State: Device is a fluid barrier film containing an antimicrobial agent

Definition: Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: To serve as a physical barrier during a surgical procedure to protect from transfer of microorganisms, body fluids, and particulate material. The added antimicrobial agent is intended to reduce the risk of microbial contamination of the surgical site.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Surgical wound and skin

Regulation Number: 878.4370

Third Party Flag: Y

Medical Specialty: SU

Device Identifiers

Device Id: 20612479223657

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: 10612479224701

Device Type: Unit of Use

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: 40612479223668

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20612479223657

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

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