FDA.reportPublic FDA data

ESTCARBON

Primary DI
04744946011978
Brand
ESTCARBON
Company
Erismet OU
Model
N1094
Device description
Estcarbon Narrow Carbon Fiber Insole, W12-12.5/M11-11.5 (10.94 inch)
Published
2024-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
04744946011220PreviousGS10
04744946011978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04744946011220047449460112204744946011220
04744946011978047449460119784744946011978

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+37256248826info@estcarbon.com

Regulatory Flags#

DUNS number
565510255
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04744946011787ESTCARBON AS382024-10-29
04744946011770ESTCARBON AS372024-10-28
04744946011749ESTCARBON LS12282024-09-20
04744946011756ESTCARBON LS12562024-09-20
04744946011763ESTCARBON LS12832024-09-20
04744946010094ESTCARBON N11732024-09-09
04744946010100ESTCARBON N1152024-09-09
04744946010209ESTCARBON N8942024-09-09
04744946010308ESTCARBON N11222024-09-09
04744946011886ESTCARBON N9212024-09-09
04744946011893ESTCARBON N9452024-09-09
04744946011909ESTCARBON N9692024-09-09
04744946011930ESTCARBON N9922024-09-09
04744946011947ESTCARBON N1022024-09-09
04744946011954ESTCARBON N10432024-09-09
04744946011961ESTCARBON N10712024-09-09
04744946012111ESTCARBON P1022024-09-09
04744946012128ESTCARBON P10432024-09-09
04744946012135ESTCARBON P10712024-09-09
04744946012142ESTCARBON P11222024-09-09

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
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
04744946012173ESTCARBON Erismet OUKYS2024-09-09