Catalog Number

CS-1000MG

Brand Name

OASIS Micro

Version/Model Number

G58764

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

K152033

Product Code

KGN

Product Code Name

Dressing, wound, collagen

Public Device Record Key

06ce3fbd-3b96-46bb-a662-2499b0ab6e50

Public Version Date

December 18, 2020

Public Version Number

1

DI Record Publish Date

December 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-