FDA.reportPublic FDA data

MEDI

Primary DI
04051526799394
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
K412812
Device description
MANUMED ACTIVE WRIST LEFT SAND S
Published
2019-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQIORTHOSIS, LIMB BRACE
ISZUNIT, WRIST, EXTERNAL LIMB COMPONENT, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1
ISZUnit, Wrist, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04051526799394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051526799394040515267993944051526799394

GMDN Terms#

Term, Definition table
TermDefinition
Wrist orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags#

DUNS number
960754430
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636257192283MEDI205572026-06-01
00636257214749MEDI107S512026-06-01
00636257214756MEDI107S522026-06-01
00636257214763MEDI107S532026-06-01
00636257214770MEDI107S542026-06-01
00636257214787MEDI107S552026-06-01
00636257214794MEDI107S562026-06-01
00636257214800MEDI107S572026-06-01
00636257214817MEDI108S512026-06-01
00636257214824MEDI108S522026-06-01
00636257214831MEDI108S532026-06-01
00636257214848MEDI108S542026-06-01
00636257214855MEDI108S552026-06-01
00636257214862MEDI108S562026-06-01
00636257214879MEDI108S572026-06-01
00636257214886MEDI195S512026-06-01
00636257214893MEDI195S522026-06-01
00636257214909MEDI195S532026-06-01
00636257214916MEDI195S542026-06-01
00636257214923MEDI195S552026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179882464CopperfitIdeavillage Products CorpIQI2026-06-01
00810179882471CopperfitIdeavillage Products CorpIQI2026-06-01
00810079192656Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192663Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192670Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192687Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192694Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192700Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192717Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192724Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192731Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192748Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192755Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192762Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192779Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192786Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192793Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192809Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192816Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192823Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192946Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192953Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192960Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192977Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192984Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192991Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193004Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193011Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193028Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00636257213322MEDIMEDI MANUFACTURING, INC.IQI2026-04-24