Introducer D3.5 mm, 167 mm, Trocar.

Basic Information

• Brand Name: Introducer D3.5 mm, 167 mm, Trocar.
• Primary DI: 07290015487139
• Version / Model: FAC9200000
• Catalog Number: FAC9200000
• Company Name: ICECURE MEDICAL LTD
• Labeler DUNS: 514758619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-24
• Public Version: 7
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: a0a81bbe-c93a-459b-a745-81f195f26e41

Device Description

Consists of Mandrel (FAC9200000-1) and Cannula (FAC9200000-2)

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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GDF	Guide, Needle, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65809	Percutaneous non-endoscopic instrument access cannula	A hollow slender tubular instrument designed for percutaneous insertion to provide access for instruments (e.g., biopsy needle) under radiological image guidance [e.g., ultrasound] during procedures relating to tissue lesions (e.g., biopsy, ablation). The cannula includes a sharp trocar blade/mandrel to assist introduction and is intended for soft tissue access, however it might additionally be intended for non-impactive bone access. It is not a dedicated bone access cannula and is not an endoscopic (laparoscopic, arthroscopic) access cannula. Some types include a guide to help percutaneous insertion (e.g., during transperineal prostate biopsy). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290015487139	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	3.5	Millimeter
Shaft Length	167	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas.