Sterile Micro Needle ELLISYS ST

Basic Information

• Brand Name: Sterile Micro Needle ELLISYS ST
• Primary DI: 08809495930807
• Version / Model: CWM-930S_ELLISYS ST-C25
• Company Name: Chungwoo Co., Ltd.
• Labeler DUNS: 689894533
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-25
• Public Version: 2
• Public Version Date: 2024-09-03
• Public Version Status: Update
• Public Device Record Key: 347baa8b-ee40-4363-9f53-f0cf7c085170

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63582	Resective skin contouring/liposuction system needle/cannula kit	A collection of devices intended to be used to tighten loose or wrinkled skin and, optionally, cosmetically remove fat, through rotational force and suction provided by a dedicated console. It consists of a multiple coring needle array used to create a matrix of small circular holes in the skin which subsequently heal with contraction, a lipectomy cannula to be inserted subcutaneously into the fat layer for the aspiration of adipose tissue (fat), and a single coring needle for creating an opening in the skin for insertion of the lipectomy cannula. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809495930807	GS1

Customer Contacts

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