Duns Number:801895244
Device Description: Intrauterine Insemination Catheter
Catalog Number
-
Brand Name
Select IUI
Version/Model Number
SM400
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K954099,K954099
Product Code
MFD
Product Code Name
Cannula, Intrauterine Insemination
Public Device Record Key
690e7663-f5d3-4b17-9ef1-426ef5b735cc
Public Version Date
January 23, 2019
Public Version Number
4
DI Record Publish Date
August 09, 2016
Package DI Number
20888937003592
Quantity per Package
25
Contains DI Package
00888937003598
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 | 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 |