Non
McKesson - 16-1007
Device Description
A non-sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
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 IdentifiersDevice Id: 40612479217346
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20612479217335
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 20612479217335
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: 10612479225920
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
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