Duns Number:092519016
Catalog Number
-
Brand Name
P/Z QC HIGH
Version/Model Number
P/Z QC H U F ML
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
f4d10f59-cf60-4df0-b7bd-45dafcc57f14
Public Version Date
May 10, 2022
Public Version Number
1
DI Record Publish Date
May 02, 2022
Package DI Number
B80002942500061
Quantity per Package
4
Contains DI Package
B80002942500060
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 113 |