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MIRRAGEN® Advanced Wound Matrix

FDA UDI

Class U (US FDA UDI)

by Ets Wound Care Llc

Identity

Trade Name
MIRRAGEN® Advanced Wound Matrix FDA UDI
Generic Name
Synthetic wound matrix dressing FDA UDI
Device Name
Resorbable Borate Glass Wound Management Device FDA UDI
Model / Reference
MET-0101 FDA UDI
Description
Resorbable Borate Glass Wound Management Device FDA UDI

Identifiers

Primary DI / UDI-DI
00812005030025 FDA UDI
510(k) Number
K161067 FDA UDI
FDA Product Code
QSZ FDA UDI
GMDN Term
Synthetic wound matrix dressing FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

MIRRAGEN® Advanced Wound Matrix by Ets Wound Care Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K161067 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ets Wound Care Llc

Sources (1)

  • FDA UDI b2d30218-764d-46e2-bde5-f526d9a138a3 36 fields · synced Jun 8, 2026