AccessGUDID - DEVICE: TRAMEDIC® TRAUMA BANDAGE (00818630011705)

GUDID

Device Identifier (DI) Information

Brand Name: TRAMEDIC® TRAUMA BANDAGE
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TR011
Company Name: TACTICAL MEDICAL SOLUTIONS, LLC

Primary DI Number: 00818630011705
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131480662 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
MHW	Dressing, Compression

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 215c4aa3-506e-421c-8beb-0f554b04e4ee
Public Version Date: February 21, 2022
Public Version Number: 2
DI Record Publish Date: October 15, 2020