Calciject - Calciject prefilled Calcium Hydroxide paste tips, - CENTRIX, INC.

Duns Number:053707303

Device Description: Calciject prefilled Calcium Hydroxide paste tips, 24

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More Product Details

Catalog Number

-

Brand Name

Calciject

Version/Model Number

320003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K001050

Product Code Details

Product Code

EJK

Product Code Name

Liner, Cavity, Calcium Hydroxide

Device Record Status

Public Device Record Key

20119ddf-ec3b-4483-9afa-256b6fbb938b

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CENTRIX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 127
U Unclassified 10