Duns Number:836287433
Catalog Number
-
Brand Name
QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01
Version/Model Number
1679000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JQJ
Product Code Name
DENSITOMETERIC, PROTEIN FRACTIONATION
Public Device Record Key
2df0deb5-4387-4545-8180-ea2958aa6053
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
March 17, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 152 |
2 | A medical device with a moderate to high risk that requires special controls. | 214 |