Catalog Number

PGPS002

Brand Name

Progel™ Pleural Air Leak Sealant

Version/Model Number

PGPS002

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

Yes

FDA Premarket Submission

P010047,P010047

Product Code

NBE

Product Code Name

Sealant,polymerizing

Public Device Record Key

a3644c1f-3ed3-47f9-b3b9-ef452ca4c89b

Public Version Date

February 21, 2022

Public Version Number

4

DI Record Publish Date

September 12, 2014

Package DI Number

10801741010023

Quantity per Package

4

Contains DI Package

00801741010026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA