Duns Number:600487813
Catalog Number
-
Brand Name
Body Form Tampons
Version/Model Number
BBFAP08-0
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
cc431ac8-b06a-47ad-b88a-89229b8a4604
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
October 31, 2016
Package DI Number
10659205264082
Quantity per Package
24
Contains DI Package
00659205264085
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 11 |