Duns Number:176664068
Device Description: Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers a Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes.
Catalog Number
-
Brand Name
Tourni-Cot - Universal
Version/Model Number
TCU
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
K853472,K853472
Product Code
GAX
Product Code Name
Tourniquet, Nonpneumatic
Public Device Record Key
90bd6d09-ac52-47ba-a869-e0f253925d18
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 23, 2020
Package DI Number
10855364004082
Quantity per Package
20
Contains DI Package
00855364004085
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |