Catalog Number

85.1441

Brand Name

S-Monovette®-Needle

Version/Model Number

85.1441

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

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

c6887783-d44c-4aa7-a387-f5219ebd5487

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

04038917005197

Quantity per Package

1000

Contains DI Package

04038917086660

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-