Duns Number:129529337
Device Description: 3 Ply Proback European Bib 13" X 18" Dark Blue
Catalog Number
PG-C125-DBDB
Brand Name
PlastCare
Version/Model Number
PG-C125-DBDB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KHR
Product Code Name
Absorber, Saliva, Paper
Public Device Record Key
7d749d3a-d95e-459d-b801-cb77e5c01771
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 02, 2021
Package DI Number
D066PGC125DBDB2
Quantity per Package
4
Contains DI Package
D066PGC125DBDB1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 9 |