Catalog Number

8881682135

Brand Name

Monoject

Version/Model Number

8881682135

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)

-

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

97c176a0-17c2-4454-b5ec-649b6aefe3b6

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 27, 2018

Package DI Number

30884521027651

Quantity per Package

12000

Contains DI Package

20884521027654

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE