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Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)

FDA UDI

Class II (US FDA UDI)

by Aroa Biosurgery

Identity

Trade Name
Myriad Ultra™ Reinforced BioScaffold – Permanent (PP) FDA UDI
Generic Name
Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
Device Name
Myriad Ultra ™ Reinforced Tissue Matrix is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper). Myriad™ is intended for applications in plastic and reconstructive surgery or to cover, protect and provide a moist wound environment. The device may be fixed, via sutures, staples or tacks to surround the tissue if desired. FDA UDI
Model / Reference
LP04PP1520 FDA UDI
Description
Myriad Ultra ™ Reinforced Tissue Matrix is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper). Myriad™ is intended for applications in plastic and reconstructive surgery or to cover, protect and provide a moist wound environment. The device may be fixed, via sutures, staples or tacks to surround the tissue if desired. FDA UDI

Identifiers

Catalog Number
LP04PP1520 FDA UDI
Primary DI / UDI-DI
09421906661880 FDA UDI
510(k) Number
K153632 FDA UDI
FDA Product Code
FTL FDA UDI
FTM FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Width — 15 Centimeter FDA UDI
Length — 20 Centimeter FDA UDI

Myriad Ultra™ Reinforced BioScaffold – Permanent (PP) by Aroa Biosurgery — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153632 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aroa Biosurgery

Sources (1)

  • FDA UDI 1d00eec2-b3b9-4218-a3a2-e8044db472ba 38 fields · synced Jun 8, 2026