FDA.reportPublic FDA data

FlexiOH

Primary DI
08908014765002
Brand
FlexiOH
Company
JC ORTHOHEAL PRIVATE LIMITED
Model
Short Arm Immobilizer XXS
Device description
FlexiOH Short Arm Immobilizer is indicated for Distal radius stable fracture , wrist fracture and wrist sprain.
Published
2020-06-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908014765002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908014765002089080147650028908014765002

GMDN Terms#

Term, Definition table
TermDefinition
Hand orthosisAn externally applied orthopaedic appliance or apparatus 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from direct sun light

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 201 565 7633contact@orthoheal.com

Regulatory Flags#

DUNS number
877234002
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536801074PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536801081PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536806390PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823571PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823588PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823595PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823601PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823618PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823625PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823632PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823649PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823656PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823663PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823670PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823687PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823694PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823700PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824165PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824172PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824189PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824196PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824202PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824219PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824226PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824233PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824240PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824257PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824264PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824271PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824769PediHipORTHOPEDIATRICS CORP.IQI2026-10-01