Non
Dornier MedTech - Dornier Genesis Urology Drain Bag
Device Description
A non-sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device intended to be sterilized prior to use.
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: 10810116023032
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00810116023035
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 00810116023035
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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