Catalog Number

4730

Brand Name

IvyAIR Meniscus System, Curved

Version/Model Number

4730

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

-

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

2a876fee-14d0-4bab-8091-bb9440cc715b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-