Duns Number:006261481
Device Description: CATHETER SA6AR105 SA 6F 5PK 100CM AR10
Catalog Number
-
Brand Name
SHERPA NX ACTIVE
Version/Model Number
SA6AR105
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2020
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
K042489,K042489
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
be9594e6-27ec-4e12-a9cb-85bb3f4f58eb
Public Version Date
September 22, 2022
Public Version Number
8
DI Record Publish Date
May 30, 2016
Package DI Number
20613994842231
Quantity per Package
5
Contains DI Package
00613994842237
Package Discontinue Date
June 22, 2020
Package Status
Not in Commercial Distribution
Package Type
PK
| 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 |