Duns Number:112853395
Device Description: WATER RESISTANT MULTI-PURPOSE TUBE HOLDER
Catalog Number
-
Brand Name
CATH-SECURE PLUS
Version/Model Number
5445-6
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
ccb76e53-39d0-4926-b698-f3e838da9549
Public Version Date
October 23, 2019
Public Version Number
1
DI Record Publish Date
October 15, 2019
Package DI Number
20048329000251
Quantity per Package
8
Contains DI Package
10048329000254
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER SHIP CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |