FDA.reportPublic FDA data

MIRRASURG™

Primary DI
00812005030346
Brand
MIRRASURG™
Company
ETS WOUND CARE LLC
Model
MSG-0404
Device description
Resorbable Borate Glass Wound Management Device
Published
2023-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00812005030346PackageGS110In Commercial Distribution
00812005030315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812005030346008120050303468120050303460812005030346
00812005030315008120050303158120050303150812005030315

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressing, non-antimicrobialA 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 does not include an antimicrobial agent(s). 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

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
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08