FDA.reportPublic FDA data

Tairuibosi

Primary DI
06974870090338
Brand
Tairuibosi
Company
TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO.,LTD.
Model
TRB-538/M9/F10
Published
2023-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06974870090338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974870090338069748700903386974870090338

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

Regulatory Flags#

DUNS number
729210247
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974870090420TairuibosiTRB-080-S2023-04-14
06974870090437TairuibosiTRB-080-M2023-04-14
06974870090444TairuibosiTRB-080-L2023-04-14
06974870090451TairuibosiTRB-080-XL2023-04-14
06974870090512TairuibosiTRB-023-CS2023-05-17
06974870090529TairuibosiTRB-023-CM2023-05-17
06974870090536TairuibosiTRB-023-CL2023-05-17
06974870090543TairuibosiTRB-023-AS2023-05-17
06974870090550TairuibosiTRB-023-AM2023-05-17
06974870090567TairuibosiTRB-023-AL2023-05-17
06974870090574TairuibosiTRB-023-AXL2023-05-17
06974870090819TairuibosiTRB-497-#92023-11-08
06974870090826TairuibosiTRB-497-#112023-11-08
06974870090833TairuibosiTRB-497-#122023-11-08
06974870090840TairuibosiTRB-497-#132023-11-08
06974870090857TairuibosiTRB-497-#142023-11-08
06974870090864TairuibosiTRB-497-#152023-11-08
06974870091182TairuibosiTRB-0562023-11-08
06974870091199TairuibosiTRB-425 S2023-11-08
06974870091205TairuibosiTRB-425 M2023-11-08

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