Duns Number:151179769
Device Description: Kroger Sport Unsc Spr 36ct w/1ct Raz Pck
Catalog Number
-
Brand Name
Playtex
Version/Model Number
08355
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060981,K060981,K060981
Product Code
HEB
Product Code Name
Tampon, menstrual, unscented
Public Device Record Key
e50b9128-8f33-4222-bf75-6e2663991175
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 01, 2020
Package DI Number
20078300083553
Quantity per Package
3
Contains DI Package
00078300083559
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 54 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |