Catalog Number

-

Brand Name

Oasis

Version/Model Number

MV-1629

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

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

a66605b2-a235-46c2-bf91-3e0706cb7e90

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

January 11, 2016

Package DI Number

B031MV16291

Quantity per Package

12

Contains DI Package

B031MV16290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-