Xpan Universal Trocar System

Basic Information

• Brand Name: Xpan Universal Trocar System
• Primary DI: 00860007212239
• Version / Model: XP1077-01
• Company Name: Xpan Inc.
• Labeler DUNS: 208914737
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-19
• Public Version: 1
• Public Version Date: 2023-09-27
• Public Version Status: New
• Public Device Record Key: da3943c6-5d61-4cdd-a237-5111f0ef45fa

Device Description

Xpan 12mm Cannula with Obturator, Standard Length (x1)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Sterilization Methods: Ethylene Oxide

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
42412	Laparoscopic access cannula, single-use	A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.	No	Active
61425	Laparoscopic trocar blade, single-use	A rigid surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860007212236	GS1	Display Box	1	In Commercial Distribution
Primary	00860007212239	GS1
Package	20860007212233	GS1	Shipper Box	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K223562	000