RECELL

Basic Information

• Brand Name: RECELL
• Primary DI: 00851707004149
• Version / Model: US 1920
• Catalog Number: C3RL01-B:US
• Company Name: AVITA MEDICAL AMERICAS, LLC
• Labeler DUNS: 026723570
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-26
• Public Version: 1
• Public Version Date: 2018-11-26
• Public Version Status: New
• Public Device Record Key: 342a3555-a0fa-476d-9aba-492f5bf9f1f2

Device Description

RECELL Autologous Cell Harvesting Device

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QCZ	Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58417	Autologous skin cell grafting kit	A collection of sterile devices designed to disaggregate cells from a split-thickness skin biopsy for immediate application to a prepared wound bed in the donor patient (skin cell autograft) to promote healing and skin cover. It typically includes a processing unit with battery-powered heater, a disassociation enzyme, a buffer solution, a spray delivery applicator, and various syringes and needles. The donor skin is prepared with heated enzyme and then scraped to create a suspension of mixed skin cell types in the buffer solution which is typically applied to the recipient site by spray or droplet. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851707004149	GS1

Premarket Submissions

Submission Number	Supplement Number
BP170122	0