- Physicians Office Resource

Laparotomy Drape ABDOMINAL 104 in x 76 in x 120 in
McKesson - 183-i80-05170G-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: 40612479229790

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10612479229782

Package Quantity: 13

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10612479229782

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

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.