Catalog Number

-

Brand Name

SERI

Version/Model Number

94680

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

K123128

Product Code

OXF

Product Code Name

Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

Public Device Record Key

cf5269c6-f55b-43e6-944e-b6fddf89dd80

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-