Protective Pediatric Mitts

Basic Information

• Brand Name: Protective Pediatric Mitts
• Primary DI: 00027479280122
• Version / Model: MTPM391M
• Catalog Number: MTPM391M
• Company Name: MEDI-TECH INTERNATIONAL CORPORATION
• Labeler DUNS: 063865158
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-23
• Public Version: 2
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: d4de62a7-76ff-40ef-a3d3-ada2cc344f1c

Device Description

Protective Pediatric Mitts - Size Toddler (1-3 Years) - Pair

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: 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
Primary	00027479280122	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110377	000