Duns Number:008965063
Device Description: SUPER PERFECTION SILK SMOOTH PLASTIC APPLICATOR UNSCENTED 18 TAMPONS
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
10002377
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
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
365868e3-34ff-4e6c-b644-6f7c27449af3
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 27, 2018
Package DI Number
10049022735375
Quantity per Package
12
Contains DI Package
00049022735378
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 | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |