FDA.reportPublic FDA data

MEDI

Primary DI
04051526104617
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
PJ07045
Device description
IGLI ALLRND LT E45/46 M11-12.5 W-
Published
2019-01-02
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
04051526104617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051526104617040515261046174051526104617

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic insole, prefabricatedA prefabricated shoe insert intended to provide supplemental support for the arch and/or heel of the foot. It is not intended to inhibit the growth of microbes. It is normally available [non-prescription] over-the-counter (OTC). 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
00636257213469MEDIDB1812026-05-07
00636257213551MEDISP171N12026-05-07
00636257213568MEDISP171N22026-05-07
00636257213575MEDISP171N32026-05-07
00636257213582MEDISP171N42026-05-07
00636257213599MEDISP171N52026-05-07
00636257213605MEDISP172N12026-05-07
00636257213612MEDISP172N22026-05-07
00636257213629MEDISP172N32026-05-07
00636257213636MEDISP172N42026-05-07
00636257213643MEDISP172N52026-05-07
00636257213650MEDISM171N12026-05-07
00636257213667MEDISM171N22026-05-07
00636257213674MEDISM171N32026-05-07
00636257213681MEDISM171N42026-05-07
00636257213698MEDISM171N52026-05-07
00636257213704MEDISM172N12026-05-07
00636257213711MEDISM172N22026-05-07
00636257213728MEDISM172N32026-05-07
00636257213735MEDISM172N42026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00636257213339MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213346MEDIMEDI MANUFACTURING, INC.IQI2026-04-24