RECELL AVRL0101

GUDID 00851707004200

RECELL Autologous Cell Harvesting Device

AVITA MEDICAL AMERICAS, LLC

Autologous skin cell grafting kit
Primary Device ID00851707004200
NIH Device Record Key816e8b17-269e-465b-b51c-e1ab74a47f27
Commercial Distribution StatusIn Commercial Distribution
Brand NameRECELL
Version Model NumberUS 1920
Catalog NumberAVRL0101
Company DUNS026723570
Company NameAVITA MEDICAL AMERICAS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851707004200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QCZMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-03
Device Publish Date2022-04-25

On-Brand Devices [RECELL]

00851707004149RECELL Autologous Cell Harvesting Device
00851707004200RECELL Autologous Cell Harvesting Device
00851707004262RECELL Autologous Cell Harvesting Device

Trademark Results [RECELL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RECELL
RECELL
86842621 5167622 Live/Registered
BioPolymer Industries, Inc.
2015-12-08
RECELL
RECELL
86456218 not registered Live/Pending
Avita Medical Ltd.
2014-11-17
RECELL
RECELL
76219207 2671209 Live/Registered
C3 OPERATIONS PTY LTD
2001-03-02
RECELL
RECELL
76219206 2803984 Dead/Cancelled
C3 OPERATIONS PTY LTD.
2001-03-02
RECELL
RECELL
74269702 1787726 Dead/Cancelled
Hoechst Aktiengesellschaft
1992-04-24

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