EP1-5G & CAT-2

Basic Information

• Brand Name: EP1-5G & CAT-2
• Primary DI: 00843356100341
• Version / Model: EP90-5G
• Company Name: CYGNUS MEDICAL L.L.C.
• Labeler DUNS: 103169095
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 3
• Public Version Date: 2022-02-08
• Public Version Status: Update
• Public Device Record Key: d8c3206d-734b-4e4b-9a7f-6e19dd4a95f5
• Distribution End Date: 2022-02-07

Device Description

EP1-5G & CAT-2 - 50 Each

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61965	Medical device cleaning sponge/set	A hand-held manual device in the form of a soft or abrasive sponge/pad, sometimes with non-medicated substances (e.g., enzymes, surfactant) and potentially other related items (e.g., receptacle), intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. 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	30843356100342	GS1
Primary	00843356100341	GS1