Duns Number:006261481
Device Description: CATHETER SB8JR40 SB 8F 100CM JR40
Catalog Number
-
Brand Name
SHERPA NX BALANCED
Version/Model Number
SB8JR40
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2017
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"
-
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
K060418
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
a7ca1f38-d261-4a03-8b54-da074f40d380
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
May 09, 2016
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |