Duns Number:016898496
Device Description: StatLock Foley Stabilization Devices, Catheter Stabilization Devices, Large Swivel Clamp o StatLock Foley Stabilization Devices, Catheter Stabilization Devices, Large Swivel Clamp on jumbo pad w/holes, includes: skin prep pad
Catalog Number
FOL0100
Brand Name
Catheter Stabilization Device
Version/Model Number
FOL0100
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
-
Product Code
EYJ
Product Code Name
HOLDER, URETERAL CATHETER
Public Device Record Key
930b8030-cf1e-4f10-921c-0af714343b9b
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
Package DI Number
20801741076071
Quantity per Package
10
Contains DI Package
10801741076074
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| 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 |