MediChoice

Basic Information

• Brand Name: MediChoice
• Primary DI: 50885632133280
• Version / Model: MTT2819
• Company Name: OWENS & MINOR DISTRIBUTION, INC.
• Labeler DUNS: 007941230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2020-10-12
• Public Version: 1
• Public Version Date: 2020-10-20
• Public Version Status: New
• Public Device Record Key: 7e194c32-d071-4488-8b9d-5af3664c5b1f

Device Description

Mitts Double Essential Secure One Size Fits All Pair No Finger Separators Double-Padded Cotton Polyester And Polyester Fiberfill Hook And Loop Wrist Closure Optional 48.75 Inch Strap Not Made With Natural Rubber Latex MediChoice

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FMQ	Restraint, protective	General Hospital	880.6760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62482	Limb/torso/head restraint, reusable	A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10885632133282	GS1
Primary	50885632133280	GS1

Premarket Submissions

Submission Number	Supplement Number
K110377	000