Duns Number:283088573
Device Description: Embryo transfer catheter used for introduction of embryos into the uterine cavity.
Catalog Number
-
Brand Name
Embryo transfer catheter
Version/Model Number
#4000 The Tulip
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
K013536,K013536,K013536
Product Code
MQF
Product Code Name
Catheter, Assisted Reproduction
Public Device Record Key
2ea35c79-d0a1-4508-aaf7-07f673c6082e
Public Version Date
August 31, 2018
Public Version Number
5
DI Record Publish Date
October 14, 2016
Package DI Number
25425017501316
Quantity per Package
75
Contains DI Package
05425017501312
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |