FDA.report

Formthotics

Primary DI
09419430003085
Brand
Formthotics
Company
FOOT SCIENCE INTERNATIONAL LIMITED
Model
FM01-OrShA-Re-2S
Device description
Formthotics Medical Original Single Hard - XXS
Published
2024-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IQIOrthosis, Limb Brace

Product Code Classifications

CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09419430003085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09419430003085094194300030859419430003085

GMDN Terms

TermDefinition
Orthotic insole, prefabricated, antimicrobialA prefabricated orthopaedic shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot, whilst inhibiting microbes such as viruses, bacteria and fungi. It is typically made of fabric and/or synthetic polymer materials (e.g., wool, viscose, silicone gel, foam) impregnated with an antimicrobial substance, which is designed to resist extreme load and may provide thermal insulation. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
590255113
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
false
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 DIBrandModelCatalogPublished
09419430015361FormthoticsFM01-LpDmB-Bg-2S2025-07-17
09419430015378FormthoticsFM01-LpDmB-Bg-XS2025-07-17
09419430015385FormthoticsFM01-LpDmB-Bg-SM2025-07-17
09419430015392FormthoticsFM01-LpDmB-Bg-ME2025-07-17
09419430015408FormthoticsFM01-LpDmB-Bg-LA2025-07-17
09419430015415FormthoticsFM01-LpDmB-Bg-XL2025-07-17
09419430015422FormthoticsFM01-LpDmA-Bg-2L2025-07-17
09419430015446FormthoticsFM01-SfDmBpBg-XS2025-07-17
09419430015453FormthoticsFM01-SfDmBpBg-SM2025-07-17
09419430015460FormthoticsFM01-SfDmBpBg-ME2025-07-17
09419430015477FormthoticsFM01-SfDmBpBg-LA2025-07-17
09419430015484FormthoticsFM01-SfDmBpBg-XL2025-07-17
09419430015491FormthoticsFM01-SfDmApBg-2L2025-07-17
09419430015514FormthoticsFM01-WfDmA-Bg-2S2025-07-17
09419430015521FormthoticsFM01-WfDmA-Bg-XS2025-07-17
09419430015538FormthoticsFM01-WfDmA-Bg-SM2025-07-17
09419430015545FormthoticsFM01-WfDmA-Bg-ME2025-07-17
09419430015552FormthoticsFM01-WfDmA-Bg-LA2025-07-17
09419430015569FormthoticsFM01-WfDmA-Bg-XL2025-07-17
09419430015576FormthoticsFM01-WfDmA-Bg-2L2025-07-17

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