Duns Number:023904428
Device Description: Intermittent Catheter HYDROPHILIC STERILE WATER PACKET STRAIGHT TIP FEMALE PVC Intermittent Catheter HYDROPHILIC STERILE WATER PACKET STRAIGHT TIP FEMALE PVC STERILE 8 Inch 14 Fr
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-FH814
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
K111405,K111405,K111405
Product Code
GBM
Product Code Name
Catheter, Urethral
Public Device Record Key
31543970-9bdc-4485-84eb-cb09c69bfa9f
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
January 07, 2019
Package DI Number
40612479242485
Quantity per Package
10
Contains DI Package
20612479242474
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |