Catalog Number

-

Brand Name

DynaClip Forte

Version/Model Number

3000-06-302020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

951ae6d9-4c4d-4c22-b8b1-a6a2b6cdaa1f

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

May 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-