Duns Number:080935429
Device Description: Midstream Specimen Catch Kit,Castile Soap Towelettes
Catalog Number
24035
Brand Name
Dover
Version/Model Number
24035
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 17, 2023
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
38ad7c67-52b1-4334-9435-f1b7b25e6396
Public Version Date
March 04, 2022
Public Version Number
3
DI Record Publish Date
June 29, 2018
Package DI Number
10884521008182
Quantity per Package
50
Contains DI Package
20884521008189
Package Discontinue Date
February 17, 2023
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |