Duns Number:131084188
Device Description: SAM Junctional Tourniquet - Hand Pump
Catalog Number
-
Brand Name
SAM(R) Junctional Tourniquet
Version/Model Number
SJT113
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2021
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
K131561
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
e226a842-491d-46e4-b9fc-cdfcc31ca763
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
October 01, 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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 3 |