Catalog Number

PGEN005-11

Brand Name

Progel™Extended Applicator Spray Tip

Version/Model Number

PGEN005-11

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

Product Code

NBE

Product Code Name

Sealant,polymerizing

Public Device Record Key

5dcb9ca9-7b8e-4bc8-926e-bf3121ee244a

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2014

Package DI Number

10801741010016

Quantity per Package

4

Contains DI Package

00801741010019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA