Catalog Number

PI1610/75

Brand Name

PenBone

Version/Model Number

PI1610/75

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 14, 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

fb73b9b1-e0f4-4e1f-9f06-0f806f4eef54

Public Version Date

May 27, 2021

Public Version Number

4

DI Record Publish Date

June 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-