OPTICS ONE

Basic Information

• Brand Name: OPTICS ONE
• Primary DI: 00815384023213
• Version / Model: MTI-2500
• Catalog Number: MTI-2500
• Company Name: MEDICAL TECHNIQUE, INC.
• Labeler DUNS: 790514756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cbf85e43-a8b2-414b-99ac-a7ad3643b124

Device Description

Armboard Straps 1 x 30

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: 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
NZD	Stretcher, Patient Restraint	General Hospital	880.6900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35304	Arm restraint	A non-rigid device, typically a strap or band made of various materials (e.g., fabric, nylon, leather, foam), used to temporarily secure a patient's arm(s) to a fixture or furniture part (e.g., bedrail, chair, table leg) to restrict the patient's physical activity for the prevention of potential injury or hazards. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00815384023220	GS1	INNER PACK	10	In Commercial Distribution
Primary	00815384023213	GS1

Customer Contacts

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