Duns Number:961027315
Device Description: Maxi PadCurity6.26 x 12.2 in. (15.9 x 31.0 cm)Ultra thinUnscentedOvernight with wingsMater Maxi PadCurity6.26 x 12.2 in. (15.9 x 31.0 cm)Ultra thinUnscentedOvernight with wingsMaterials of fabrication: Topsheet (skin contact): is bicomponent Polyethylene / Polypropylene Acquistion Distribution Layer: is a nonwoven hightloft layer made of polyesterAbsorbent Core: cellulose fibers with a super absorbent polymerBacksheet (external layer): is a nonwoven made of polyethyleneIncludes a release silicone paper and polyolefin adhesives in the seams and joints
Catalog Number
FH-PADORG
Brand Name
Curity
Version/Model Number
FH-PADORG
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"
Yes
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
36b6047c-3c28-42a6-83f1-ceb57b548927
Public Version Date
July 29, 2020
Public Version Number
1
DI Record Publish Date
July 21, 2020
Package DI Number
50192253023877
Quantity per Package
12
Contains DI Package
20192253023876
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |