Duns Number:016898496
Device Description: Magic3 Go 12 Fr Male Coude Catheter with SureGrip
Catalog Number
50812G
Brand Name
Magic3 Go Male Coude Catheter with SureGrip
Version/Model Number
50812G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
9e750226-16e6-497f-8e37-fa9cc5970855
Public Version Date
May 31, 2019
Public Version Number
1
DI Record Publish Date
May 23, 2019
Package DI Number
20801741137017
Quantity per Package
360
Contains DI Package
10801741137010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |