Endoform Myriad - Myriad is intended for applications in plastic - AROA BIOSURGERY LIMITED

Duns Number:594540572

Device Description: Myriad is intended for applications in plastic and reconstructive surgery or to cover, pro 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.

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More Product Details

Catalog Number

SR05LG0505US

Brand Name

Endoform Myriad

Version/Model Number

MR05LG0505

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162461,K171231

Product Code Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

096df0ad-cb49-4178-aa31-da115b8fdded

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

March 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AROA BIOSURGERY LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 135
U Unclassified 33