Duns Number:007941230
Device Description: Pad Obstetric 2.75 Inch X 10 Inch Super Maxi With Adhesive Strip Individually Wrapped Not Pad Obstetric 2.75 Inch X 10 Inch Super Maxi With Adhesive Strip Individually Wrapped Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
FH1002
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)
-
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
28e4ee17-d48f-4567-9b79-dba6fa644d37
Public Version Date
September 07, 2020
Public Version Number
1
DI Record Publish Date
August 28, 2020
Package DI Number
30885632064924
Quantity per Package
12
Contains DI Package
40885632064921
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |