Catalog Number

1180327114E

Brand Name

Monoject

Version/Model Number

1180327114E

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

-

Product Code

EIC

Product Code Name

SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Public Device Record Key

6165be05-7197-42b8-a3e0-bd6761e6850e

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 22, 2018

Package DI Number

20884521195544

Quantity per Package

100

Contains DI Package

10884521195547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK