Catalog Number

637

Brand Name

Pantex P637SP

Version/Model Number

P637SP

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"

-

For Single-Use

-

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

f5fc413b-7693-42b3-a4fd-e3061f39ba75

Public Version Date

May 31, 2022

Public Version Number

1

DI Record Publish Date

May 23, 2022

Package DI Number

10850039602327

Quantity per Package

1

Contains DI Package

00850039602320

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box