Sound Body

Basic Information

• Brand Name: Sound Body
• Primary DI: 00017276228434
• Version / Model: 017276228434
• Company Name: Aso LLC
• Labeler DUNS: 152793493
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-09-27
• Public Version: 2
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: aeb3d313-f023-473b-b6fe-2fcfab002d09
• Distribution End Date: 2023-02-14

Device Description

Antibacterial Flexible Fabric, Extra Large Adhesive Bandages, all one size, 2 IN x 4 IN (50 mm x 101 mm)

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47378	Skin-cover adhesive strip, antimicrobial	A small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20017276228438	GS1	case	72	Not in Commercial Distribution	2023-02-14
Primary	00017276228434	GS1
Unit of Use	60017276228436	GS1

Customer Contacts

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