Catalog Number

40045

Brand Name

Ceramir® Protect LC Syringe

Version/Model Number

40045

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

EJK

Product Code Name

Liner, Cavity, Calcium Hydroxide

Public Device Record Key

aaac96f9-cca7-49ca-80ab-0aadee8879b8

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-