CORE DYNAMICS

Basic Information

• Brand Name: CORE DYNAMICS
• Primary DI: 10653405045861
• Version / Model: CD612
• Catalog Number: CD612
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0c5e8ec8-ab1f-4cee-ab90-766616169a9a

Device Description

5/10/12mm ENTREE® II Valve/Reducer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
FBM	Cannula and trocar, suprapubic, non-disposable	Gastroenterology, Urology	876.5090	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61699	Laparoscopic access cannula anchor, reusable	A small, luminal device designed to enable a laparoscopic access cannula (port) to be secured to the skin/tissue of an incision site during a laparoscopic surgical procedure. The outer surface is typically textured/ribbed and intended to grip the tissue whilst the laparoscopic access cannula is inserted through the device lumen and fixed at the required insertion depth using a clamping mechanism. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20653405045868	GS1	BOX	10	In Commercial Distribution
Primary	10653405045861	GS1
Unit of Use	00653405045864	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K911813	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5/10/12 Millimeter Outer Diameter ENTREE II Valve/Reducer