Catalog Number

-

Brand Name

IMPROVACUTER® Gel & Clot Activator Tube

Version/Model Number

16×100mm,8ml

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

22dd4157-3ce3-4f7f-963d-3df8db45d01d

Public Version Date

July 05, 2022

Public Version Number

1

DI Record Publish Date

June 27, 2022

Package DI Number

46974481831489

Quantity per Package

20

Contains DI Package

16974481831488

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-