Duns Number:072943876
Device Description: OVERNIGHT ULTRA THIN MAXIPAD w/ WINGS UNSCENTED 14CNT
Catalog Number
-
Brand Name
TOPCARE
Version/Model Number
10002122
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
ce054f1d-a585-4767-891b-59a7bae8560d
Public Version Date
August 11, 2020
Public Version Number
1
DI Record Publish Date
August 03, 2020
Package DI Number
10036800041384
Quantity per Package
12
Contains DI Package
00036800041387
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |