Catalog Number

4720

Brand Name

Stryker AIR™

Version/Model Number

4720

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2017

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

K153087

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

af585717-33c3-4c88-a543-eb9b61a7efbc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-