Catalog Number

n/a

Brand Name

Neoligaments TM

Version/Model Number

102-1040

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 21, 2021

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

JDR

Product Code Name

Staple, Fixation, Bone

Public Device Record Key

4613ff1c-0a7c-4633-aed8-df4259604fb0

Public Version Date

July 29, 2021

Public Version Number

7

DI Record Publish Date

October 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-