FDA.reportPublic FDA data

MIRRAGEN® Advanced Wound Matrix

Primary DI
00812005030117
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
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
00812005030117PackageGS110In 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
Cavity-wound management dressingA non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent). It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00812005030087MIRRAGEN® Advanced Wound MatrixMES-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

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Primary DI, Brand, Company table
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05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
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10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
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10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
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