Duns Number:006261481
Device Description: CATHETER SB7JL45 SB 7F 100CM JL45
Catalog Number
-
Brand Name
SHERPA NX BALANCED
Version/Model Number
SB7JL45
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 03, 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
K051846
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
8d5546ed-e765-4c9f-a2ad-b45e7c8abe81
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
May 12, 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 |