EZ SCULPT

Basic Information

• Brand Name: EZ SCULPT
• Primary DI: 00860009682177
• Version / Model: EZ-2003
• Company Name: Jordan Consulting Group, LLC
• Labeler DUNS: 080664909
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2023-02-24
• Public Version: 1
• Public Version Date: 2023-03-06
• Public Version Status: New
• Public Device Record Key: ce736bd9-58d7-4bd5-9776-1913ddc0eed0

Device Description

EZ Sculpt Disp. Microcannula, 22x2 (22x50mm)

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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	00860009962927	GS1	Box	20	In Commercial Distribution
Primary	00860009682177	GS1
Package	00860009941427	GS1	Carton	4	In Commercial Distribution
Unit of Use	00860009941472	GS1

Customer Contacts

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