Catalog Number

39-SP-0720

Brand Name

Reform TI Pedicle Screw System

Version/Model Number

39-SP-0720

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

HXX

Product Code Name

Screwdriver

Public Device Record Key

5911339a-cbbd-40dc-9b41-a55271d51cf3

Public Version Date

May 22, 2019

Public Version Number

1

DI Record Publish Date

May 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-