Duns Number:131084188
Device Description: SAM Junctional Tourniquet Trainer - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand SAM Junctional Tourniquet Trainer - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag
Catalog Number
-
Brand Name
SAM® Junctional Tourniquet
Version/Model Number
JT402-EN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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,K131561,K131561
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
08b5b65b-33aa-4cec-96c7-9cc60a144d22
Public Version Date
July 28, 2021
Public Version Number
3
DI Record Publish Date
September 25, 2019
Package DI Number
10822045000343
Quantity per Package
6
Contains DI Package
00822045000346
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |