Catalog Number

CPA00019B

Brand Name

SafeStep

Version/Model Number

CPA00019B

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

PTI

Product Code Name

Non-Coring (Huber) Needle

Public Device Record Key

1cc38f1a-7180-4f98-a7a5-3c5695c5a5c5

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

January 26, 2018

Package DI Number

10801741153287

Quantity per Package

5

Contains DI Package

00801741153280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA