Catalog Number

-

Brand Name

IMPROVACUTER® Gel & Clot Activator Tube

Version/Model Number

13x100mm,6ml

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093910,K093910,K093910

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

b4aa67a9-f454-46af-9d20-6df04ebfb650

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

December 26, 2016

Package DI Number

46933395621302

Quantity per Package

10

Contains DI Package

16933395621301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-