Duns Number:005744772
Device Description: QC microPSD sensor cable
Catalog Number
PSD-QC5N
Brand Name
QC microPSD
Version/Model Number
PSD-QC5N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
Yes
For Single-Use
-
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
-
Product Code
NZT
Product Code Name
Dosimeter, Ionizing Radiation, Implanted
Public Device Record Key
c426d9e0-9d42-4307-9ba3-fb6324dc4e24
Public Version Date
June 14, 2019
Public Version Number
1
DI Record Publish Date
June 06, 2019
Package DI Number
20851546007169
Quantity per Package
32
Contains DI Package
10851546007162
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |