CORE E3™

Basic Information

• Brand Name: CORE E3™
• Primary DI: 20653405986680
• Version / Model: CD8185-B
• Catalog Number: CD8185-B
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2021-11-05
• Public Version: 2
• Public Version Date: 2024-02-13
• Public Version Status: Update
• Public Device Record Key: 3ee8c27f-3226-4a80-94ce-34f7cbc03807

Device Description

Suction/Irrigator, 5mm x 32cm Probe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47890	Disposable surgical irrigation/aspiration system	A device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30653405986687	GS1	Box	1	In Commercial Distribution
Primary	20653405986680	GS1
Unit of Use	00653405986686	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY; KEEP OUT OF SUNLIGHT
• Type: Storage Environment Humidity
• Temperature Range: 30 – 65 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius