Catalog Number

930545028

Brand Name

Screw 4.5 x 28mm s/s self-tapping

Version/Model Number

930545028

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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"

Yes

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

3665a4b3-6cc4-492b-9452-8427c4a2af30

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 04, 2016

Package DI Number

EMAH9305450281

Quantity per Package

1

Contains DI Package

EMAH9305450280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-