Duns Number:151179769
Device Description: SF UT REG WLESS OC 18CT 8/CS
Catalog Number
-
Brand Name
Stayfree
Version/Model Number
02460
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
768b25fb-0f03-49cf-a11a-9cb67e49dcef
Public Version Date
April 09, 2020
Public Version Number
1
DI Record Publish Date
April 01, 2020
Package DI Number
00078300030713
Quantity per Package
6
Contains DI Package
00078300024606
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 54 |
2 | A medical device with a moderate to high risk that requires special controls. | 65 |