Catalog Number

-

Brand Name

Oasis

Version/Model Number

SHARP-1Q

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

K101567,K101567

Product Code

MMK

Product Code Name

Container, Sharps

Public Device Record Key

508abc97-f410-44e4-a61b-c0e872d8ba2c

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 21, 2018

Package DI Number

B031SHARP1Q1

Quantity per Package

100

Contains DI Package

B031SHARP1Q0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case