Catalog Number

11-0076

Brand Name

N/A

Version/Model Number

11-0076

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 27, 2020

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

-

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

HXK

Product Code Name

HOLDER, NEEDLE; ORTHOPEDIC

Public Device Record Key

b259f7c6-4a43-4ad8-84ea-96cbb58ccf76

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

August 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-