- Physicians Office Resource

Leggings CLEAR PE FILM STERILE 33 in x 52 in
McKesson - 183-i80-11115-S

Device Description

A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). 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: 40612479229950

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10612479229942

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10612479229942

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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