Duns Number:005527098
Device Description: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Strai No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Tip, Protective Tip and Sleeve
Catalog Number
-
Brand Name
VaPro Plus
Version/Model Number
74124-30
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
K141642,K141642
Product Code
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
a0a4051d-aa6a-49f1-86a5-2a873d3f2c6f
Public Version Date
October 06, 2022
Public Version Number
6
DI Record Publish Date
September 02, 2016
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |