Duns Number:089055867
Device Description: CATHETER 95001 KIT ANTIMICROBIAL
Catalog Number
-
Brand Name
ARES™
Version/Model Number
95001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110560
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
0c9a9372-98db-4e05-ae36-067cf4bcb20b
Public Version Date
December 06, 2021
Public Version Number
3
DI Record Publish Date
July 01, 2015
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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 1465 |