Duns Number:228480810
Device Description: Cystometry 8fr & rectal catheter set
Catalog Number
-
Brand Name
Mediplus
Version/Model Number
5108
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
KGZ
Product Code Name
ACCESSORIES, CATHETER
Public Device Record Key
1d1b99be-c975-4ebb-ab67-053e87a058db
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
15055140700725
Quantity per Package
10
Contains DI Package
05055140700728
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 | 33 |
2 | A medical device with a moderate to high risk that requires special controls. | 95 |