Duns Number:215591523
Catalog Number
-
Brand Name
Portex
Version/Model Number
CE123
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 27, 2019
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
-
Product Code
MQF
Product Code Name
CATHETER, ASSISTED REPRODUCTION
Public Device Record Key
9dc84d52-1133-4b62-a763-a4dcfd912d8c
Public Version Date
October 16, 2019
Public Version Number
4
DI Record Publish Date
October 23, 2017
Package DI Number
35019315012475
Quantity per Package
10
Contains DI Package
15019315012471
Package Discontinue Date
September 27, 2019
Package Status
Not in Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 332 |
2 | A medical device with a moderate to high risk that requires special controls. | 431 |