Duns Number:790584176
Device Description: ActivaPatch IntelliDose 2.5 Sample Pack (2)
Catalog Number
SA89188
Brand Name
ActivaPatch IntelliDose 2.5 Sample
Version/Model Number
00140-SAMPLE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
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
EGJ
Product Code Name
Device, Iontophoresis, Other Uses
Public Device Record Key
d51966a7-4d7f-4242-914c-836e2fa0cc01
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 22, 2016
Package DI Number
10859975005155
Quantity per Package
20
Contains DI Package
00859975005158
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |