CORE DYNAMICS

Basic Information

• Brand Name: CORE DYNAMICS
• Primary DI: 20653405045738
• Version / Model: CD412
• Catalog Number: CD412
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-06-07
• Public Version Status: Update
• Public Device Record Key: 51722a32-260b-4e2a-bc20-0da7d6430263
• Distribution End Date: 2022-06-06

Device Description

10/12mm Fascia Anchor Adapter for Entree® Plus and Entree® II Cannula, Reusable

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
Direct Marking	30653405045735	GS1
Primary	20653405045738	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K932021	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10/12 Millimeter Fascia Anchor Adaptor for ENTREE Plus and ENTREE II Cannula