Duns Number:801895244
Device Description: Contents: One SpermSelect System and one TheCurve
Catalog Number
-
Brand Name
SpermSelect Curve Kit
Version/Model Number
SM603-F
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012935
Product Code
MFD
Product Code Name
Cannula, Intrauterine Insemination
Public Device Record Key
a75db9e2-e6ce-480b-bd6a-29d78ba48b79
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 09, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |