Catalog Number

PGST009

Brand Name

Progel™ Applicator Spray Tips

Version/Model Number

PGST009

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

-

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

-

FDA Premarket Submission

P010047,P010047,P010047

Product Code

NBE

Product Code Name

Sealant,polymerizing

Public Device Record Key

9c0e7abe-5e95-4190-930d-2924c7fe98eb

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2014

Package DI Number

20801741010037

Quantity per Package

10

Contains DI Package

10801741010030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA