Duns Number:007941230
Device Description: Overnight Obstetric pad Individually wrapped Secure adhesive strip 3X12 Green backing/ whi
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
FH1003
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
0308b4eb-a2d9-4b1a-b107-85d18833cc33
Public Version Date
September 17, 2020
Public Version Number
1
DI Record Publish Date
September 09, 2020
Package DI Number
20885632064934
Quantity per Package
24
Contains DI Package
40885632064938
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 |