FDA.reportPublic FDA data

Aurix Ten Pack Kit

Primary DI
10852714003153
Brand
Aurix Ten Pack Kit
Company
Nuo Therapeutics, Inc.
Model
AGWR-04
Device description
Aurix Ten Pack Kit Case of 10 Wound Dressing Kits and 10 Reagent Kits with 010513 Aurix Ten Pack Kit Label
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PMQPeripheral Blood Processing Device For Wound Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMQPeripheral Blood Processing Device For Wound ManagementHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0600070

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0600070

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852714003153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085271400315310852714003153

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicated, sterileA collection of sterile instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118447207
Device count
1
Kit
true
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
008527140032484TRAUXP-4TR2024-03-21
00852714003194Aurix Multifly 4-PackAUXP-0012023-03-27
10852714003108Aurix Wound Dressing KitAGSW-022016-09-30
10852714003122Aurix Single Pack KitAUSP-012016-09-30
10852714003139Aurix Five Pack KitAUSP-052016-09-30
10852714003146Aurix Eight Pack KitAUSP-082016-09-30
00852714003095Aurix CentrifugeAGSC-042016-09-30
00852714003101Aurix Wound Dressing KitAGSW-022016-09-30
00852714003118Aurix Reagent KitAGSR-032016-09-30
00852714003224Aurix XL PlusAUXP-4T2025-10-06
00852714003279CentrioCentrio PRP System- Single Kit2025-09-01
00852714003286CentrioCentrio PRP System - 5 Kits2025-09-01
00852714003293CentrioCentrio PRP System - 10 Kits2025-09-01
00852714003309CentrioCentrio PRP System - Office Single Kit2025-09-01
00852714003316CentrioCentrio Multifly Needle - 4 Pack2025-09-01
00852714003323CentrioWound Dressing Kit2025-09-01
00852714003330CentrioReagent Kit2025-09-01
00852714003347CentrioOffice Wound Dressing Kit2025-09-01
00852714003187Aurix XLAUXP-2T2023-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850033131192Cellular MembraneRegenlab USA LLCPMQ2025-12-04
00850033131178RegenKit-ATS-T-URegenlab USA LLCPMQ2025-10-31
00850033131185RegenKit-ATS-3-URegenlab USA LLCPMQ2025-10-31
00850047730305Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00852714003279CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003286CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003293CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003309CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003323CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003330CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003347CentrioNuo Therapeutics, Inc.PMQ2025-09-01
10860000244319ActiGraftREDDRESS LTDPMQ2025-03-23
00860000244312ActiGraftREDDRESS LTDPMQ2025-03-23
008527140032484TRNuo Therapeutics, Inc.PMQ2024-03-21
00850033131093RegenKit Wound-GelRegenlab USA LLCPMQ2024-03-12
00850047730008Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730015Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730022Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730039Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730046Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730053Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730060Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730077Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
07640138981616RegenPlasma/RegenKit-Woud Gel-2REGEN LAB SAPMQ2023-01-19
057141883018083CP™ CounterbalanceReapplix ApSPMQ2019-05-23
057141883080053CP™ Centrifuge KitReapplix ApSPMQ2019-05-23