Duns Number:170199058
Device Description: MAXIPAD ULTRA THIN REGULAR w/WINGS UNSCENTED
Catalog Number
-
Brand Name
Care One
Version/Model Number
659420
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
HHD
Product Code Name
Pad, Menstrual, Unscented
Public Device Record Key
5158fbc5-aa38-4c89-84e8-a86664a25953
Public Version Date
January 18, 2021
Public Version Number
1
DI Record Publish Date
January 08, 2021
Package DI Number
10041520141306
Quantity per Package
6
Contains DI Package
00041520141309
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 | 28 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |
U | Unclassified | 2 |