Duns Number:097462979
Device Description: Adult Tourniquet Kit w/Snare, Custom Kit, Non-Sterile
Catalog Number
TOU-7907
Brand Name
Surge Cardiovascular
Version/Model Number
TOU-7907
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
-
Product Code
GDJ
Product Code Name
Clamp, Surgical, General & Plastic Surgery
Public Device Record Key
aa9cd06c-4dbd-448f-900a-daeec0f74bc1
Public Version Date
September 21, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10817278011716
Quantity per Package
4
Contains DI Package
00817278011726
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 91 |