Duplex

Basic Information

• Brand Name: Duplex
• Primary DI: 00843356101065
• Version / Model: DCB2017
• Company Name: CYGNUS MEDICAL L.L.C.
• Labeler DUNS: 103169095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: d85f9828-4142-424f-973f-76a19e69792d

Device Description

DUAL-CAVITY instrument transport bag

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PXV	General Purpose Instrument Tray	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64018	Instrument hygienic-transportation bag	A non-sterile flexible plastic container intended to collect and contain an instrument(s) [e.g., an endoscope] following an invasive procedure, for hygienic transportation of the device to a reprocessing facility. It is typically a drawstring bag/wrap which may be designed to be laid flat on the procedure tray/trolley during the procedure and then closed to contain the device; it is not a drape/cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30843356101066	GS1
Primary	00843356101065	GS1