SoftFil® EasyGuide

Basic Information

• Brand Name: SoftFil® EasyGuide
• Primary DI: 03760246604079
• Version / Model: CEGS2560
• Company Name: SOFT MEDICAL AESTHETICS
• Labeler DUNS: 261575410
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-16
• Public Version: 2
• Public Version Date: 2023-11-21
• Public Version Status: Update
• Public Device Record Key: 74adf7cd-09b7-4e14-b3f7-ba71dfb32217
• Distribution End Date: 2023-09-11

Device Description

SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its protective cap, - 1 stainless steel blunt-tip needle (micro-cannula) 25G X 60 mm graduated every centimeter along the tube in its protective cap

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: 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
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46676	Tissue injection cannula	A thin, sterile, semi-rigid or rigid metal tube intended to be inserted percutaneously for the injection of a substance into the cutaneous or subcutaneous layers. It is typically used for the administration of fillers [e.g., hyaluronic acid (HA)] to add volume to tissue for cosmetic or reconstructive purposes. The device is typically designed with a closed-off nose and a lateral hole at the distal tip, and a connector at the proximal end for attachment to a device that propels the injection substance. It is typically made of high-grade stainless steel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03760246600569	GS1	Box	20	Not in Commercial Distribution	2023-09-11
Primary	03760246604079	GS1