FDA.reportPublic FDA data

MEDI

Primary DI
00400000327174
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
STS0640
Device description
!STANS SHOES PF PRO INSOLE SZ 40
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00400000327174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00400000327174004000003271744000003271740400000327174

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic insole, prefabricated, non-antimicrobialA prefabricated shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot; it does not include an antimicrobial agent(s). This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
960754430
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636257215913MEDIDW51L522026-08-21
00636257215920MEDIDW51L532026-08-21
00636257215937MEDIDW51L542026-08-21
00636257215944MEDIDW51R522026-08-21
00636257215951MEDIDW51R532026-08-21
00636257215968MEDIDW51R542026-08-21
04068903520939MEDIK2102512026-08-21
04068903520946MEDIK2102522026-08-21
04068903520953MEDIK2102532026-08-21
04068903520960MEDIK2102542026-08-21
04068903520977MEDIK2102552026-08-21
00400000326986MEDISTS04352026-07-20
00400000326993MEDISTS04372026-07-20
00400000327006MEDISTS04392026-07-20
00400000327013MEDISTS04412026-07-20
00400000327020MEDISTS04432026-07-20
00400000327037MEDISTS04452026-07-20
00400000327044MEDISTS04472026-07-20
00400000327051MEDISTS05352026-07-20
00400000327068MEDISTS05372026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840536824349PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824356PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824363PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824370PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824387PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824394PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
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