Duns Number:966665036
Device Description: InCup with THC/OPI300/METH/BZO/MDMA/COC/BAR
Catalog Number
10-7SPC-283
Brand Name
INCUP
Version/Model Number
10-7SPC-283
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
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
K073078,K073078
Product Code
LAG
Product Code Name
High Pressure Liquid Chromatography, Methamphetamine
Public Device Record Key
37a4027f-f757-49bf-8641-611fd6a5f946
Public Version Date
August 21, 2020
Public Version Number
1
DI Record Publish Date
August 13, 2020
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |