Catalog Number

-

Brand Name

Oasis

Version/Model Number

MV-8685

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080684,K080684,K080684

Product Code

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Public Device Record Key

cf3f2c64-5e2b-466a-91b2-1ca3a1fd92df

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

January 14, 2016

Package DI Number

B031MV86851

Quantity per Package

12

Contains DI Package

B031MV86850

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-