Catalog Number

-

Brand Name

Oasis

Version/Model Number

DR1826

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

a996df29-10fe-42de-8184-e3eadf161fc0

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

June 24, 2019

Package DI Number

DR18261

Quantity per Package

300

Contains DI Package

DR18260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box