Catalog Number

PIP1510/50

Brand Name

PenBone

Version/Model Number

PIP1510/50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2021

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

DWO

Product Code Name

Needle, Biopsy, Cardiovascular

Public Device Record Key

0f314b19-dbe8-4442-83d5-6f3c6f50933d

Public Version Date

May 27, 2021

Public Version Number

6

DI Record Publish Date

March 14, 2017

Package DI Number

08058341213469

Quantity per Package

10

Contains DI Package

08058341213940

Package Discontinue Date

April 26, 2021

Package Status

Not in Commercial Distribution

Package Type

-