RECELL

Primary DI
00851707004262
Brand
RECELL
Company
AVITA MEDICAL AMERICAS, LLC
Model
US 480
Catalog number
AVRL0102
Device description
RECELL Autologous Cell Harvesting Device
Published
2023-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QWYMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWYMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With ApplicatorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BP2207990

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP2207990

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851707004262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851707004262008517070042628517070042620851707004262

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
026723570
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851707004361RECELL GO miniAVRL01052025-01-22
00851707004279RECELL GOAVRL01042024-05-30
00851707004286RECELL GOAVRL01032024-05-30
00851707004200RECELLUS 1920AVRL01012022-04-25
00851707004149RECELLUS 1920C3RL01-B:US2018-10-26