Duns Number:195251595
Device Description: Progel Pleural Air Leak Sealant
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
Device Class | Device Class Description | No of Devices |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 5 |