FDA.reportPublic FDA data

MEDI

Primary DI
00636257207673
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
DW41R52
Device description
!DO PREMIUM WRIST BRACE RIGHT S
Published
2025-09-11
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257207673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257207673006362572076736362572076730636257207673

GMDN Terms#

Term, Definition table
TermDefinition
Wrist orthosisA prefabricated (non-customized) 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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636257050521MEDI193S012024-01-13
00636257220733MEDIFS124352026-10-12
00636257220740MEDIFS124362026-10-12
00636257220757MEDIFS124372026-10-12
00636257220764MEDIFS124382026-10-12
00636257220771MEDIFS124392026-10-12
00636257220788MEDIFS124402026-10-12
00636257220795MEDIFS124412026-10-12
00636257220801MEDIFS124422026-10-12
00636257220887MEDIFS124432026-10-12
00636257220894MEDIFS124442026-10-12
00636257220900MEDIFS124452026-10-12
00636257220917MEDIFS124462026-10-12
00636257220924MEDIFS124472026-10-12
00636257220931MEDIFS124482026-10-12
00636257220948MEDIFS129352026-10-12
00636257220955MEDIFS129362026-10-12
00636257220962MEDIFS129372026-10-12
00636257220979MEDIFS129382026-10-12
00636257220986MEDIFS129392026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257220733MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220740MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220757MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220764MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220771MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220788MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220795MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220801MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220887MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220894MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220900MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220917MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220924MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220931MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220948MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220955MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220962MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220979MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220986MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220993MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221006MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221068MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221075MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221082MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00840536824288PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824295PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824301PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824318PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824325PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824332PediHipORTHOPEDIATRICS CORP.IQI2026-10-07