CONTROL WRAP, 4"

Basic Information

• Brand Name: CONTROL WRAP, 4"
• Primary DI: 00818630010319
• Version / Model: A
• Catalog Number: CW4
• Company Name: TACTICAL MEDICAL SOLUTIONS, LLC
• Labeler DUNS: 131480662
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-15
• Public Version: 2
• Public Version Date: 2021-12-08
• Public Version Status: Update
• Public Device Record Key: 0ec24631-bb78-4588-856c-a08f79d5750e

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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQM	Bandage, Elastic	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818630010319	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]