Duns Number:801895244
Device Description: Intrauterine Inseminator, 3.5 French, 4.5" Long, with Syringe
Catalog Number
-
Brand Name
The Inseminator
Version/Model Number
920012-1
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
K984306,K984306
Product Code
MFD
Product Code Name
Cannula, Intrauterine Insemination
Public Device Record Key
933b3e90-3edd-4e44-b783-be47ab4b6e41
Public Version Date
January 23, 2019
Public Version Number
4
DI Record Publish Date
August 25, 2016
Package DI Number
20888937011481
Quantity per Package
50
Contains DI Package
00888937011487
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| 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 |