Sound Body

Basic Information

• Brand Name: Sound Body
• Primary DI: 00017276236590
• Version / Model: 017276236590
• Company Name: Aso LLC
• Labeler DUNS: 152793493
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2020-04-29
• Public Version: 2
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: 6da998b3-cb74-4f6b-9bb6-b9ef1885e67f
• Distribution End Date: 2022-10-17

Device Description

Smart-Flex Performance Adhesive Bandages, all one size 2 3/4 N x 3 1/2 IN (70 mm x 89 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: 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: 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
32207	Skin-closure adhesive strip	A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20017276236594	GS1	case	72	Not in Commercial Distribution	2022-10-17
Primary	00017276236590	GS1
Unit of Use	60017276236592	GS1

Customer Contacts

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