AccessGUDID - DEVICE: CONTROL WRAP, 4" (00818630010319)

GUDID

Device Identifier (DI) Information

Brand Name: CONTROL WRAP, 4"
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CW4
Company Name: TACTICAL MEDICAL SOLUTIONS, LLC

Primary DI Number: 00818630010319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131480662 *Terms of Use

Device Description: 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 material Unrolled bandage dimensions: 4" or 6" x 48"

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?
10284	Pressure bandage, non-latex, single-use	A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQM	Bandage, Elastic

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 0ec24631-bb78-4588-856c-a08f79d5750e
Public Version Date: December 08, 2021
Public Version Number: 2
DI Record Publish Date: October 15, 2020