Duns Number:796354509
Device Description: PRO EMBRYO TRANS - Embryo Transfer Catheter
Catalog Number
PEB-ETC
Brand Name
Pro Embryo Trans
Version/Model Number
Pro Embryo Trans ET Catheter
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
K200248,K200248
Product Code
MQF
Product Code Name
Catheter, Assisted Reproduction
Public Device Record Key
71f515bf-9c31-4298-8633-6ef8cfe81d1c
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 18, 2020
Package DI Number
10819374020579
Quantity per Package
10
Contains DI Package
00819374020572
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 47 |