Duns Number:006959555
Device Description: MULTI PACK SCENTED PLASTIC APPLICATOR TAMPONS
Catalog Number
-
Brand Name
MEIJER TAMPONS
Version/Model Number
ME13612SA
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050067,K050067,K050067
Product Code
HIL
Product Code Name
Tampon, Menstrual, Scented, Deodorized
Public Device Record Key
173c31a7-997f-42b1-9ec0-47a7c0934593
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10719283200119
Quantity per Package
12
Contains DI Package
00719283200112
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |