FlexiOH

Basic Information

• Brand Name: FlexiOH
• Primary DI: 08908014765002
• Version / Model: Short Arm Immobilizer XXS
• Company Name: JC ORTHOHEAL PRIVATE LIMITED
• Labeler DUNS: 877234002
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-29
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6dec5c9e-4816-4e2a-92a9-4debe61390d7
• Distribution End Date: 2020-12-31

Device Description

FlexiOH Short Arm Immobilizer is indicated for Distal radius stable fracture , wrist fracture and wrist sprain.

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: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQI	Orthosis, Limb Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41457	Hand orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus intended to be used to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries or to improve function of the hand. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08908014765002	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			XXS

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from direct sun light