Duns Number:884718776
Device Description: URETHRAL CATHETER TRAY.CONTENTS: URETHRAL PVC CATHETER 14FR., VINYL GLOVES (2), PVP SWABST URETHRAL CATHETER TRAY.CONTENTS: URETHRAL PVC CATHETER 14FR., VINYL GLOVES (2), PVP SWABSTICKS (3), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, SPECIMEN CONTAINER 2oz, OUTER BASIN TRAY, WRAP.
Catalog Number
-
Brand Name
GLOBAL HEALTHCARE
Version/Model Number
60-TN1401
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCM
Product Code Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Public Device Record Key
d5eb598b-485f-4675-88e7-f4faca8b368d
Public Version Date
August 06, 2020
Public Version Number
3
DI Record Publish Date
February 10, 2017
Package DI Number
40872237008566
Quantity per Package
10
Contains DI Package
00872237008568
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 62 |