Catalog Number

-

Brand Name

PenAdapt

Version/Model Number

PA2010BCB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2022

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

-

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

-

FDA Premarket Submission

-

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Public Device Record Key

1b726836-6b96-4663-8c69-45d2ac27cc82

Public Version Date

April 22, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10815198012516

Quantity per Package

10

Contains DI Package

00815198012519

Package Discontinue Date

April 21, 2022

Package Status

Not in Commercial Distribution

Package Type

Case