FDA.reportPublic FDA data

Comforsil

Primary DI
08431082070902
Brand
Comforsil
Company
PRIM S.A.
Model
CC250
Catalog number
800423
Device description
"Nocturnal ""Hallux Valgus"" bunion corrector, pair"
Published
2024-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KYSInsoles, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYSInsoles, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08431082070902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08431082070902084310820709028431082070902

GMDN Terms#

Term, Definition table
TermDefinition
Hallux valgus metatarsophalangeal orthosisA prefabricated (non-customized) non-rigid, home-use device intended to be worn on the foot to help prevent and/or reduce hallux valgus deformity, thereby reducing walking pain and bunion formation. It is made of elastic fabric materials and may encompass only the metatarsophalangeal region or extend around the heel for tensioning. This is a single-patient reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
462011560
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
08431082070186ComforsilCC209S2024-03-08
08431082070193ComforsilCC209M2024-03-08
08431082070209ComforsilCC209L2024-03-08
08431082070216ComforsilCC209XL2024-03-08
08431082070391ComforsilCC218M2024-03-08
08431082070773ComforsilCC2452024-03-08
08431082070810ComforsilCC206S2024-03-08
08431082070827ComforsilCC206M2024-03-08
08431082070834ComforsilCC206L2024-03-08
08431082070841ComforsilCC218S8003982024-03-08
08431082070858ComforsilCC218L8003962024-03-08
08431082070896ComforsilCC2492024-03-08
08434048106349ComforgelCG04017364482024-03-08
08434048106554ComforgelCG05017364692024-03-08
08434048352784PrimspinePRS615G OS8247262024-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04744946011787ESTCARBON Erismet OUKYS2024-10-29
04744946011794ESTCARBON Erismet OUKYS2024-10-29
04744946011800ESTCARBON Erismet OUKYS2024-10-29
04744946011817ESTCARBON Erismet OUKYS2024-10-29
04744946011824ESTCARBON Erismet OUKYS2024-10-29
04744946011831ESTCARBON Erismet OUKYS2024-10-29
04744946011848ESTCARBON Erismet OUKYS2024-10-29
04744946011923ESTCARBON Erismet OUKYS2024-10-29
04744946011770ESTCARBON Erismet OUKYS2024-10-28
04744946011749ESTCARBON Erismet OUKYS2024-09-20
04744946011756ESTCARBON Erismet OUKYS2024-09-20
04744946011763ESTCARBON Erismet OUKYS2024-09-20
04744946010094ESTCARBON Erismet OUKYS2024-09-09
04744946010100ESTCARBON Erismet OUKYS2024-09-09
04744946010209ESTCARBON Erismet OUKYS2024-09-09
04744946010308ESTCARBON Erismet OUKYS2024-09-09
04744946011886ESTCARBON Erismet OUKYS2024-09-09
04744946011893ESTCARBON Erismet OUKYS2024-09-09
04744946011909ESTCARBON Erismet OUKYS2024-09-09
04744946011930ESTCARBON Erismet OUKYS2024-09-09
04744946011947ESTCARBON Erismet OUKYS2024-09-09
04744946011954ESTCARBON Erismet OUKYS2024-09-09
04744946011961ESTCARBON Erismet OUKYS2024-09-09
04744946011978ESTCARBON Erismet OUKYS2024-09-09
04744946012111ESTCARBON Erismet OUKYS2024-09-09
04744946012128ESTCARBON Erismet OUKYS2024-09-09
04744946012135ESTCARBON Erismet OUKYS2024-09-09
04744946012142ESTCARBON Erismet OUKYS2024-09-09
04744946012159ESTCARBON Erismet OUKYS2024-09-09
04744946012166ESTCARBON Erismet OUKYS2024-09-09