Catalog Number

62-310

Brand Name

Miltex®

Version/Model Number

62-310

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 20, 2017

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

K092855

Product Code

DZL

Product Code Name

SCREW, FIXATION, INTRAOSSEOUS

Public Device Record Key

05022543-9a72-4bf8-aef7-1f5338d17e27

Public Version Date

January 22, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-