Catalog Number

8213-3000-10

Brand Name

OASIS

Version/Model Number

G57608

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

Product Code

KGN

Product Code Name

Dressing, wound, collagen

Public Device Record Key

52db7051-1e6b-428c-bef0-05ff5697b582

Public Version Date

May 20, 2021

Public Version Number

2

DI Record Publish Date

March 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-