Catalog Number

-

Brand Name

Oasis

Version/Model Number

DR6080

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

0e2391b7-1f92-479f-af5f-a869946bde6f

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2019

Package DI Number

B031DR60801

Quantity per Package

75

Contains DI Package

B031DR60800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box