Catalog Number

-

Brand Name

Oasis

Version/Model Number

MV-J338

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

K073614,K073614,K073614

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

569ab9da-cd79-4c63-87bb-bc704626c748

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 14, 2016

Package DI Number

B031MVJ3381

Quantity per Package

12

Contains DI Package

B031MVJ3380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-