Catalog Number

HCT99BP-V

Brand Name

HCT

Version/Model Number

HCT99BP-V

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

-

Product Code

OKE

Product Code Name

Port introducer kit

Public Device Record Key

c4820090-4437-4c75-99a5-46a2983946a4

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

38498840010052

Quantity per Package

20

Contains DI Package

08498840010051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-