FDA.report

ESTCARBON

Primary DI
04744946010674
Brand
ESTCARBON
Company
Erismet OU
Model
M992
Device description
Morton's Extension Carbon Fiber Insole, W9/M8-8.5 (9.92 inch)
Published
2024-02-20
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
false

Related Records

Product Codes

CodeName
KYSInsoles, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
KYSInsoles, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04744946010674PrimaryGS10

GMDN Terms

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

Contacts

PhoneEmail
9999999999info@estcarbon.com

Regulatory Flags

DUNS number
565510255
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
04744946011787ESTCARBON AS382024-10-29
04744946011794ESTCARBON AS392024-10-29
04744946011800ESTCARBON AS402024-10-29
04744946011817ESTCARBON AS412024-10-29
04744946011824ESTCARBON AS422024-10-29
04744946011831ESTCARBON AS432024-10-29
04744946011848ESTCARBON AS442024-10-29
04744946011923ESTCARBON AS452024-10-29
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

Other Devices Sharing Product Codes

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