Catalog Number

55-OS-4512

Brand Name

Reform POCT System

Version/Model Number

55-OS-4512

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

K162300,K172495

Product Code

NKG

Product Code Name

Posterior Cervical Screw System

Public Device Record Key

c203ba3a-3c31-4a45-86d6-15450fef20cd

Public Version Date

May 14, 2019

Public Version Number

1

DI Record Publish Date

May 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-