Duns Number:305524696
Device Description: Ureteral Dilator (CH FR 12-14, length 48 cm)
Catalog Number
RBD014
Brand Name
Porges Coloplast
Version/Model Number
RBD014
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"
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
K170531,K170531
Product Code
EZN
Product Code Name
DILATOR, CATHETER, URETERAL
Public Device Record Key
a1cc3c24-23b3-4c25-a8b2-5034a36a9621
Public Version Date
July 08, 2019
Public Version Number
1
DI Record Publish Date
June 30, 2019
Package DI Number
03600040300510
Quantity per Package
10
Contains DI Package
03600040300503
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |