Incise surgical drape
OPSITE INCISE 15X28CM CTN 10 - 4986
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: KGX
Device Name: Tape And Bandage, Adhesive
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 880.5240
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 05000223049867
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223415495
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton
Device Id: 05000223415495
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: 05000223414894
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223049867
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case