MediChoice

Basic Information

• Brand Name: MediChoice
• Primary DI: 20885632070713
• Version / Model: GZBN4003
• Company Name: OWENS & MINOR DISTRIBUTION, INC.
• Labeler DUNS: 007941230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-09-16
• Public Version: 1
• Public Version Date: 2020-09-24
• Public Version Status: New
• Public Device Record Key: 41754c3c-6517-4296-9f53-750629783434

Device Description

Gauze Bandage Roll Bulk Non-Sterile 4.5" x 4.1 yd Large 100% Cotton White 6-Ply Single Use Only Not Made With Natural Rubber Latex

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAB	Gauze / sponge,nonresorbable for external use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48126	Woven gauze roll, non-sterile	A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10885632070716	GS1
Primary	20885632070713	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 75 Percent (%) Relative Humidity