Duns Number:131480662
Device Description: The OLAES® Modular Bandage is the newest generation of trauma bandages and is advantageous The OLAES® Modular Bandage is the newest generation of trauma bandages and is advantageous for all levels of care providers. Packed with features such as 3 meters of gauze, a removable occlusive plastic sheet behind the trauma dressing pad, and a pressure bar that can also act as an eye cup, the advanced capabilities of the medical bandage are tucked neatly away and can be utilized if required or simply ignored. No hooks or clips to confuse or delay care. Velcro® 'Control' strips prevent the elastic roll from accidentally unraveling and secure the emergency bandage throughout the application process. This OLAES® dressing is designed with direct input from some of the most experienced combat medics in the world, no detail has been left out. From the adhesive 'brakes' on the elastic bandage that prevent accidental unrolling to the zig-zag packed gauze that easily feeds from the bandage, this is the most comprehensive feature packed bandage available without any added confusion. No other medical dressing bandage offers so much versatility in such a small package. Cover minor wounds, apply truly effective pressure dressings, apply occlusive dressings, and have the ability to pack severe wounds with one OLAES® Modular Trauma Bandage. Application Efficiency:During high stress situations, such as those involving casualties, stress effects on human performance often affect the fine motor skills of individuals. This makes simple tasks such as bandage application more difficult and time consuming. By creating a pressure bandage where application involves only gross motor skills, no direction changes around hooks or bars, the Olaes® Modular Bandage significantly offers a simpler and more effective solution in bandage dressing options. The elastic combat dressing simply requires wrapping where the elastic stays flat instead of turning into a cord. Control of the elastic roll is maintained by the 'Control Strips' should the elastic be dropped. You no longer have to open or
Catalog Number
OAL-4
Brand Name
4" OLAES MODULAR BANDAGE
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
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
fe8e4175-520c-4939-b831-3cc0f7678fe6
Public Version Date
February 21, 2022
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 |