Catalog Number
-
Brand Name
NA
Version/Model Number
101160-03
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 08, 2018
Issuing Agency
In GS1
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080934,K091154,K132889,K983341
Product Code
JAQ
Product Code Name
System, applicator, radionuclide, remote-controlled
Public Device Record Key
7090c387-f54f-47fe-9921-433820c92c72
Public Version Date
September 10, 2018
Public Version Number
2
DI Record Publish Date
June 14, 2018
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1904 |