Catalog Number

8881310448

Brand Name

Monoject

Version/Model Number

8881310448

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

K771052,K771052,K771052

Product Code

GIM

Product Code Name

Tubes, vacuum sample, with anticoagulant

Public Device Record Key

1adf99f3-dff0-46eb-aef6-1d5a44460cde

Public Version Date

April 23, 2019

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

20884527006592

Quantity per Package

1000

Contains DI Package

10884527006595

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE