Restrata Meshed - The Restrata Wound Matrix is a sterile, single - Acera Surgical Inc

Duns Number:040631370

Device Description: The Restrata Wound Matrix is a sterile, single use device intended for use in local manage The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.

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More Product Details

Catalog Number

-

Brand Name

Restrata Meshed

Version/Model Number

RMESH-3X3

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

-

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

c5a877f6-12ed-4909-96d9-436ddddaf130

Public Version Date

April 29, 2022

Public Version Number

1

DI Record Publish Date

April 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACERA SURGICAL INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6
U Unclassified 17