Catalog Number

-

Brand Name

CP Disposable Kit with 45mm Lightning Needle

Version/Model Number

CLPT-PK-101-45

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

-

Product Code Name

-

Public Device Record Key

75154cda-c899-4eaa-8f4c-7266b2feb358

Public Version Date

July 23, 2020

Public Version Number

2

DI Record Publish Date

February 26, 2020

Package DI Number

M896CLPTPK101451

Quantity per Package

1

Contains DI Package

M896CLPTPK101450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-