Duns Number:131480662
Device Description: Tactical Medical Solutions® designed the Control Wrap to make life a little easier when un Tactical Medical Solutions® designed the Control Wrap to make life a little easier when under stress. Just as in our OLAES® and BLAST® Bandages, we incorporate a series of brakes into each elastic bandage. These brakes prevent accidental un-rolling during application. The brakes also provide grip surfaces during the wrapping process and assist in maintaining the desired pressure and position of the bandage. This is extremely helpful when changing angles during the wrapping process or if bandaging awkward injuries. By reducing the risk of accidental unrolling of the bandage, you minimize the following risks: Contaminating a clean bandage Waste of a bandage due to contamination Lost time while managing loose ends Loss of pressure after applying the bandage due to shifting of materialUnrolled bandage dimensions: 4" or 6" x 48"
Catalog Number
CW4
Brand Name
CONTROL WRAP, 4"
Version/Model Number
A
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
0ec24631-bb78-4588-856c-a08f79d5750e
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
October 15, 2020
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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |