Catalog Number

8213-0000-18

Brand Name

OASIS

Version/Model Number

G35244

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K061711,K061711

Product Code

KGN

Product Code Name

Dressing, wound, collagen

Public Device Record Key

47b8fbe3-5130-464a-999e-41a37fb1a06e

Public Version Date

May 20, 2021

Public Version Number

2

DI Record Publish Date

March 11, 2019

Package DI Number

10827002352442

Quantity per Package

5

Contains DI Package

00827002352445

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-