DEVICE: 4" OLAES MODULAR BANDAGE, TRAINING VERSION (00818630011675)

Device Identifier (DI) Information

4" OLAES MODULAR BANDAGE, TRAINING VERSION
A
In Commercial Distribution
OAL-4T
TACTICAL MEDICAL SOLUTIONS, LLC
00818630011675
GS1

1
131480662 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
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No
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47011 First aid absorbent pad/bandage
A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
MHW Dressing, Compression
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8c1568c1-9bf2-4f2f-a789-46d82651f18a
February 21, 2022
2
October 15, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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864-224-0081
info@tacmedsolutions.com
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