Catalog Number

SDG1-000

Brand Name

PRECICE® Trauma Nail System

Version/Model Number

SDG1-000

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

-

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

HTJ

Product Code Name

Gauge, Depth

Public Device Record Key

a7dd319c-ad4e-4143-9d09-e83fa7e514e3

Public Version Date

December 07, 2018

Public Version Number

3

DI Record Publish Date

January 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-