Duns Number:305524696
Device Description: Chiba puncture needles percutaneous nephrostomy set, 18G (ø 1.3 mm), 20 cm, Stainless stee Chiba puncture needles percutaneous nephrostomy set, 18G (ø 1.3 mm), 20 cm, Stainless steel
Catalog Number
RAC018
Brand Name
Porges Coloplast
Version/Model Number
RAC018
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
-
Product Code
GBO
Product Code Name
CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
Public Device Record Key
9624a82a-834e-4f5a-9d2f-631523c7f78a
Public Version Date
July 10, 2020
Public Version Number
1
DI Record Publish Date
July 02, 2020
Package DI Number
05708932730167
Quantity per Package
5
Contains DI Package
05708932730150
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 |