Duns Number:006959555
Device Description: MULTI PACK UNSCENTED PLASTIC APPLICATOR TAMPONS
Catalog Number
-
Brand Name
MEIJER TAMPONS
Version/Model Number
ME93606UA
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
-
Product Code
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
8ee6c4c9-397f-4fb4-920d-8e073ca7812d
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10719283200102
Quantity per Package
6
Contains DI Package
00719283200105
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 |