Duns Number:145963778
Device Description: Disinfecting Towelettes Canister of Pre-Saturated Towelettes
Catalog Number
-
Brand Name
CaviWipes
Version/Model Number
13-1100
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRJ
Product Code Name
Disinfectant, medical devices
Public Device Record Key
d6f62d88-5672-40c6-bfc2-aeeff13ac201
Public Version Date
October 13, 2021
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
10615375005016
Quantity per Package
12
Contains DI Package
00615375005019
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |