FDA.reportPublic FDA data

MIRRAGEN® Advanced Wound Matrix

Primary DI
00812005030087
Brand
MIRRAGEN® Advanced Wound Matrix
Company
ETS Wound Care LLC
Model
MES-0101
Device description
Resorbable Borate Glass Wound Management Device
Published
2020-02-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSZAbsorbable Synthetic Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161067000Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”Engineered Tissue Solutions, LLC2016-09-15QSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812005030117PackageGS110Not in Commercial Distribution
00812005030087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812005030117008120050301178120050301170812005030117
00812005030087008120050300878120050300870812005030087

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic wound matrix dressingA sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
573-202-2550support@etswoundcare.com

Regulatory Flags#

DUNS number
080578874
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812005030537Mirragen Advanced Wound Matrix7.5 cm x 7.5 cmMWM-075-075EA2026-03-03
B477MWM0106EA0MIRRAGEN® Advanced Wound MatrixMWM-01062020-02-14
B477MWM0202EA0MIRRAGEN® Advanced Wound MatrixMWM-02022020-02-14
B477MWM0404EA0MIRRAGEN® Advanced Wound MatrixMWM-04042020-02-14
00812005030025MIRRAGEN® Advanced Wound MatrixMET-01012020-02-14
00812005030209MIRRAGEN® Advanced Wound MatrixMWM-015-0152023-07-31
00812005030223MIRRAGEN® Advanced Wound MatrixMWM-02022023-02-01
00812005030278MIRRAGEN® Advanced Wound MatrixMWM-035-0352023-07-31
00812005030285MIRRAGEN® Advanced Wound MatrixMWM-01012023-02-01
00812005030315MIRRASURG™MSG-04042023-02-01
00812005030322MIRRASURG™MSG-01062023-02-01
00812005030391MIRRAGEN® Advanced Wound MatrixMWM-045-0452024-03-06
00812005030421MIRRASURG™MSG-02022024-09-25
00812005030438MIRRAGEN® Advanced Wound MatrixMWM-025-0252024-09-25
00812005030407MIRRAGEN® Advanced Wound MatrixMWM-035-0352024-03-06
00812005030254MIRRAGEN® Advanced Wound MatrixMWM-015-0152023-07-31
00812005030377MIRRAGEN® Advanced Wound MatrixMWM-035-0352023-07-31
00812005030230MIRRAGEN® Advanced Wound MatrixMWM-02022023-02-01
00812005030292MIRRAGEN® Advanced Wound MatrixMWM-01012023-02-01
00812005030346MIRRASURG™MSG-04042023-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977727072617Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072624Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072631Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072648Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072815SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072822SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072839SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072846SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
00854258006389Restrata(R)Acera Surgical IncQSZ2026-04-15
00854258006396Restrata MeshedAcera Surgical IncQSZ2026-04-15
00850021883072SiOxD® ORSioxmed, LLCQSZ2026-03-17
00812005030537Mirragen Advanced Wound MatrixETS Wound Care LLCQSZ2026-03-03
00817337000616HyalomatrixAnika Therapeutics, Inc.QSZ2026-02-22
00850021883003SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850021883041SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850047730305Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00852513007393Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007409Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007416Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007423Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007430Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
10850021883000SiOxD Wound MatrixSioxmed, LLCQSZ2025-02-17
00852513007362ElectroFiber 3D MatrixNANOFIBER SOLUTIONS, INC.QSZ2024-11-14
00852513007379ElectroFiber 3D MatrixNANOFIBER SOLUTIONS, INC.QSZ2024-11-14
00852513007386ElectroFiber 3D MatrixNANOFIBER SOLUTIONS, INC.QSZ2024-11-14
04260184021598Suprathel®Polymedics Innovations GmbHQSZ2024-10-11