GLASSCOCK® EAR DRESSING, PEDIATRIC

Basic Information

• Brand Name: GLASSCOCK® EAR DRESSING, PEDIATRIC
• Primary DI: 00850000126022
• Version / Model: S-1003
• Company Name: Oto-Med, Inc.
• Labeler DUNS: 059817742
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 3
• Public Version Date: 2020-12-22
• Public Version Status: Update
• Public Device Record Key: 09fdab03-fd2c-420f-82e6-8912f541da16
• Distribution End Date: 2020-12-15

Device Description

GLASSCOCK® 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
Primary	00850000126022	GS1
Package	10850000126029	GS1		6	Not in Commercial Distribution

Customer Contacts

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