Sound Body

Basic Information

• Brand Name: Sound Body
• Primary DI: 00481042591105
• Version / Model: 481042591105
• Company Name: Aso LLC
• Labeler DUNS: 152793493
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-09-27
• Public Version: 3
• Public Version Date: 2023-10-31
• Public Version Status: Update
• Public Device Record Key: 55a5cf2a-5570-488c-9a02-37d4f203d739
• Distribution End Date: 2023-10-31

Device Description

Waterproof Adhesive Bandages, assorted sizes, 3/4 IN x 1 1/2 IN (19 mm x 38 mm); 3/4 IN x 2 IN (19 mm x 50 mm); 1 IN x 2 1/2 IN (25 mm x 63 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
44990	Skin-cover adhesive strip, non-antimicrobial	A small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. 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	20481042591109	GS1	case	72	Not in Commercial Distribution	2023-10-31
Primary	00481042591105	GS1
Unit of Use	60481042591107	GS1

Customer Contacts

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