Catalog Number

TKS-2

Brand Name

Biover

Version/Model Number

TKS-2

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

K011208,K011208

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

c035ed45-0bff-4385-b7c7-56eb8e0801ef

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2016

Package DI Number

7640174510030

Quantity per Package

10

Contains DI Package

07640174510023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box