ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180136229
• Version / Model: 52203-12
• Catalog Number: 52203-12
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-17
• Public Version: 1
• Public Version Date: 2019-07-25
• Public Version Status: New
• Public Device Record Key: 8e8c6d05-7a76-4b01-9599-565e6324a7f9

Device Description

12MM DIA., 6CM, STAINLESS STEEL TROCAR GUIDE CONES

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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62452	Laparoscopic multi-instrument access port, reusable	A multi-lumen sleeve assembly intended to retract a small abdominal incision to allow multiple laparoscopic instruments to access the abdominal cavity simultaneously through a single abdominal incision, during minimally-invasive laparoscopic surgery. It will include a valve component for each lumen that maintains the established pneumoperitoneum; the trocar used to create the abdominal incision might be included; it may include attached external instrument holding arms. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180136229	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181173	000