Duns Number:121170653
Device Description: Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length, non-sterile
Catalog Number
TOU-7904
Brand Name
Surge Cardiovascular
Version/Model Number
TOU-7904
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2017
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
acadef74-fad8-4fd3-879f-fab17d065459
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
20817278011300
Quantity per Package
4
Contains DI Package
10817278011303
Package Discontinue Date
July 31, 2017
Package Status
Not 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |