FlexiOH

GUDID 08908014765002

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

JC ORTHOHEAL PRIVATE LIMITED

Hand orthosis

• Primary Device ID: 08908014765002
• NIH Device Record Key: 6dec5c9e-4816-4e2a-92a9-4debe61390d7
• Commercial Distribution Discontinuation: 2020-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexiOH
• Version Model Number: Short Arm Immobilizer XXS
• Company DUNS: 877234002
• Company Name: JC ORTHOHEAL PRIVATE LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com
• Phone: +1 201 565 7633
• Email: contact@orthoheal.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sun light

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908014765002 [Primary]

FDA Product Code

• IQI: Orthosis, Limb Brace

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-07
• Device Publish Date: 2020-06-29