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

GMDN Terms#

Term, Definition table
TermDefinition
Autologous skin cell grafting kitA 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.

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