Catalog Number

H0050

Brand Name

Herculon

Version/Model Number

H0050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 02, 2019

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

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

9df0b2f8-7449-464f-b8f5-42df2c95ffdf

Public Version Date

August 17, 2020

Public Version Number

6

DI Record Publish Date

September 02, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-