Duns Number:600487813
Catalog Number
-
Brand Name
Maxithins
Version/Model Number
BUSABSMXS48
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2022
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
HHD
Product Code Name
Pad, Menstrual, Unscented
Public Device Record Key
ed17d06e-8ae5-4b12-85da-c45c78b89545
Public Version Date
May 23, 2022
Public Version Number
2
DI Record Publish Date
May 01, 2020
Package DI Number
10187933000486
Quantity per Package
6
Contains DI Package
00187933000489
Package Discontinue Date
May 01, 2022
Package Status
Not 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 |