Catalog Number

79-45143

Brand Name

DirectInject

Version/Model Number

79-45143

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

K143661

Product Code

GXP

Product Code Name

METHYL METHACRYLATE FOR CRANIOPLASTY

Public Device Record Key

cd8a567b-5527-4d64-8527-694cd9760eb4

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

December 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-