Endoform™ Antimicrobial Restorative Bioscaffold - Endoform™ Antimicrobial Restorative Bioscaffold - AROA BIOSURGERY LIMITED

Duns Number:594540572

Device Description: Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment and contains approximately 12 µg/cm² (~0.3% w/w) ionic silver, intended to inhibit colonization of the device.

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More Product Details

Catalog Number

629314

Brand Name

Endoform™ Antimicrobial Restorative Bioscaffold

Version/Model Number

629314

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K172318,K172318

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

463f8251-6163-4a72-8a01-7e3501a2c4ae

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 20, 2021

Additional Identifiers

Package DI Number

09421906017540

Quantity per Package

10

Contains DI Package

09421906017472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"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