DEVICE: TRAMEDIC® TRAUMA BANDAGE (00818630011705)

Device Identifier (DI) Information

TRAMEDIC® TRAUMA BANDAGE
A
In Commercial Distribution
TR011
TACTICAL MEDICAL SOLUTIONS, LLC
00818630011705
GS1

1
131480662 *Terms of Use
The Tramedic® Trauma Bandage is a simple, effective pressure dressing designed to treat non-life threatening hemorrhaging. It utilizes an elastic wrap material that can be used to generate pressure and a sterile wound pad that can be placed directly over the injury to aid the control of bleeding. The bandage is flat folded and vacuum-sealed to create a low profile so it can be easily stored.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

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

[?]
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

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

215c4aa3-506e-421c-8beb-0f554b04e4ee
February 21, 2022
2
October 15, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
864-224-0081
info@tacmedsolutions.com
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