Duns Number:042823948
Device Description: Amplatz Universal Drainage Catheter Ultrathane
Catalog Number
ULT14.0-38-50-P-6S-AUDC-PIG-WF
Brand Name
Amplatz
Version/Model Number
G31255
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 19, 2022
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
GBO
Product Code Name
CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
Public Device Record Key
1e90ea70-dc14-426e-9e17-e876e3aca9ba
Public Version Date
May 20, 2022
Public Version Number
3
DI Record Publish Date
October 02, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |