Duns Number:080294990
Device Description: Cora Organic Tampons - 18 Pack Regular
Catalog Number
-
Brand Name
Cora
Version/Model Number
02Tampons - 021
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 27, 2021
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
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
0480dcfa-8f13-4c1d-bfb9-43b10c88dbfd
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10850373007000
Quantity per Package
8
Contains DI Package
00850373007003
Package Discontinue Date
April 27, 2021
Package Status
Not in Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |