OmniTrustTM

Basic Information

• Brand Name: OmniTrustTM
• Primary DI: 00810572006306
• Version / Model: 9061-21
• Catalog Number: 9061-21
• Company Name: OMNI INTERNATIONAL CORP.
• Labeler DUNS: 079434709
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2019-08-27
• Public Version: 1
• Public Version Date: 2019-09-04
• Public Version Status: New
• Public Device Record Key: 62e6dbda-a1fc-4ea4-8d53-c76ac39b50bb

Device Description

Conforming Elastic Bandage, Sterile 2x75

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: No
• 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: Yes
• 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
MHW	DRESSING, COMPRESSION	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58964	Non-adhesive device retention bandage	A piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50810572006301	GS1	Shipper Carton	96	In Commercial Distribution
Primary	00810572006306	GS1
Unit of Use	10810572006303	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	2	Inch
Length	75	Inch