Duns Number:534998190
Device Description: Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 12 Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 12FR
Catalog Number
509011
Brand Name
GentleCathTM
Version/Model Number
509011
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"
-
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
5043831d-3ba4-4285-86b3-233c63478b1c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
00768455136278
Quantity per Package
10
Contains DI Package
00768455142798
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |