Duns Number:023904428
Device Description: Catheter, Foley Grip-Lok Anchor Device LG STR (100/BX)
Catalog Number
-
Brand Name
McKesson
Version/Model Number
18-3400LFC
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)
-
Over the Counter (OTC)
Yes
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
3a2738b7-e9cd-4e81-a105-e9b5821bf1c2
Public Version Date
February 09, 2022
Public Version Number
4
DI Record Publish Date
May 28, 2020
Package DI Number
00612479247970
Quantity per Package
100
Contains DI Package
00612479247963
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |