Duns Number:128990418
Device Description: MULTI PACK UNSCENTED PLASTIC APPLICATOR TAMPON
Catalog Number
-
Brand Name
SOLIMO
Version/Model Number
B07B4Y48DG
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
2fd8da95-bd06-41a1-ac8e-37452c185366
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 16, 2020
Package DI Number
20842379108109
Quantity per Package
4
Contains DI Package
00842379108105
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |