N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00840329824822
• Version / Model: B8XFIC-I-425L
• Catalog Number: B8XFIC-I-425L
• Company Name: BLACK & BLACK SURGICAL, INC.
• Labeler DUNS: 004382282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-21
• Public Version: 1
• Public Version Date: 2022-09-29
• Public Version Status: New
• Public Device Record Key: 8042d38f-c1d6-44cd-b03e-7d27af6b51db

Device Description

FAT INJECTION CANNULA TYPE I; 4MM X 25CM, LARGE HANDLE

Device Characteristics

• Single Use: No
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
45414	Liposuction system cannula, reusable	A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840329824822	GS1

Customer Contacts

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