Catalog Number

8881682010

Brand Name

Monoject

Version/Model Number

8881682010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KDC

Product Code Name

INSTRUMENT, SURGICAL, DISPOSABLE

Public Device Record Key

b8b77b1d-1107-4dbd-bf94-7bbfe4f1267c

Public Version Date

October 29, 2021

Public Version Number

4

DI Record Publish Date

June 30, 2018

Package DI Number

10884521014480

Quantity per Package

50

Contains DI Package

30884521014484

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK