Duns Number:114152184
Device Description: Intercept Collection Device
Catalog Number
-
Brand Name
Intercept
Version/Model Number
3001-2869
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
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
K011057,K011057,K011057,K011057,K011057,K011057,K011057,K011057
Product Code
PJD
Product Code Name
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Public Device Record Key
f6f83ab4-34e8-42e3-ba5a-bcdc6dd8cb68
Public Version Date
July 22, 2021
Public Version Number
6
DI Record Publish Date
July 29, 2016
Package DI Number
60608337000070
Quantity per Package
10
Contains DI Package
50608337000073
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |