Duns Number:533729471
Device Description: Slow Release Insemination Catheter
Catalog Number
EK002
Brand Name
Evie
Version/Model Number
EK002
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
-
Product Code
MQF
Product Code Name
Catheter, Assisted Reproduction
Public Device Record Key
01bdbb34-6781-460a-801a-5927dd3de015
Public Version Date
January 23, 2019
Public Version Number
3
DI Record Publish Date
November 09, 2016
Package DI Number
17290016876021
Quantity per Package
3
Contains DI Package
07290016876024
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |