Premium Trocar System

Basic Information

• Brand Name: Premium Trocar System
• Primary DI: 00607915114831
• Version / Model: C0600
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• Labeler DUNS: 187129135
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-02-08
• Public Version Status: Update
• Public Device Record Key: 0086ec8a-de76-4384-80c5-73abf433e95a
• Distribution End Date: 2018-07-23

Device Description

Laparoscopic trocar sleeve seal

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
45645	Laparoscopic access cannula seal, single-use	A small, sterile 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10607915114838	GS1		20	Not in Commercial Distribution	2018-07-23
Primary	00607915114831	GS1

Customer Contacts

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