CORE DYNAMICS

Basic Information

• Brand Name: CORE DYNAMICS
• Primary DI: 20653405044540
• Version / Model: CD111B
• Catalog Number: CD111B
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• 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: 939801ad-244e-4f06-abcc-07a42fc8c843
• Distribution End Date: 2022-06-06

Device Description

10/11mm Sealing Cap for Entree® Plus Cannula and Reducer Sleeves, Reusable

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: 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
61713	Laparoscopic access cannula seal, reusable	A small device intended to create a seal between a laparoscopic access cannula (not included) and an appropriately sized laparoscopic instrument, to inhibit the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to be fitted directly to the proximal end of the sleeve and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. 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	10653405044543	GS1	BOX	20	Not in Commercial Distribution	2022-06-06
Primary	20653405044540	GS1
Unit of Use	00653405044546	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K911813	000