Catalog Number

n/a

Brand Name

Neoligaments TM

Version/Model Number

202-3008

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 28, 2017

Issuing Agency

In GS1

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

-

Product Code

GAB

Product Code Name

Needle, Suturing, Disposable

Public Device Record Key

1c9c5a97-04b0-4506-b259-3e10d43ca322

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-