EAR DRESSING, PEDIATRIC

Basic Information

• Brand Name: EAR DRESSING, PEDIATRIC
• Primary DI: 00850000126145
• Version / Model: S-1003
• Company Name: Oto-Med, Inc.
• Labeler DUNS: 059817742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-30
• Public Version: 1
• Public Version Date: 2020-12-08
• Public Version Status: New
• Public Device Record Key: 821c1ee6-b901-4a43-ac97-cca4d9acfd0c

Device Description

EAR DRESSING, PEDIATRIC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MHW	Dressing, Compression	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34084	Wound compression dressing	A sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850000126142	GS1		6	In Commercial Distribution
Primary	00850000126145	GS1

Customer Contacts

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