Duns Number:832426782
Device Description: JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT®)For treating high extremity wounds in the thigh JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT®)For treating high extremity wounds in the thigh/groin region at or near point of injury, includes two pressure devices in a single tool, allowing for simultaneous occlusion of blood flow to both lower limbs (bilateral) with an easy to apply, pre-assembled, ready-to-use belt solution Single use.
Catalog Number
30-0088
Brand Name
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT®)
Version/Model Number
30-0088
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K123194
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
761754ea-20a2-4409-b24b-e768911b3633
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 17, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |