Duns Number:047684501
Device Description: The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile s The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.
Catalog Number
5430-30154
Brand Name
Captus 4000e Thyroid Uptake System with 2 in well
Version/Model Number
5430-30154
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
-
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
IZD
Product Code Name
Probe, Uptake, Nuclear
Public Device Record Key
3b7269e5-3e02-4e1c-8cca-f6330b490d6c
Public Version Date
July 19, 2022
Public Version Number
1
DI Record Publish Date
July 11, 2022
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 | 81 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |