FDA.reportPublic FDA data

CoreTech

Primary DI
00810113570617
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP3015BLK
Device description
Humeral Fracture Splint
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQQJoint, Shoulder, External Limb Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQQJoint, Shoulder, External Limb ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113570614PackageGS112In Commercial Distribution
00810113570617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357061410810113570614
00810113570617008101135706178101135706170810113570617

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226442535ViveLVA3192BLK2026-10-23
00810226442856ViveSUP3191BLK12CT2026-10-23
00810226443136ViveLVA3198BLK2PAK2026-10-23
00810226443068ViveLVA1006GBU2026-10-22
00810226443075ViveLVA1006PBU2026-10-22
00810226443082ViveSUP3196BLKSM2026-10-22
00810226443099ViveSUP3196BLKLXL2026-10-22
00810226443037ViveMOB1170BLK2026-10-21
00810226443044ViveMOB1170PUR2026-10-21
00810226443051ViveMOB1170TAL2026-10-21
00810226442719ViveMOB1168GRYLTH2026-10-20
00810226442726ViveMOB1168GRYAC2026-10-20
00810226443006ViveSUP3194ORG362026-10-20
00810226443013ViveSUP3195BLKSM2026-10-20
00810226443020ViveSUP3195BLKLXL2026-10-20
00810226442825ViveSUP3190BLKS2026-10-15
00810226442832ViveSUP3190BLKM2026-10-15
00810226442849ViveSUP3190BLKL2026-10-15
00810226442979Vive CareRHB3085PAK102026-10-14
00810226442870ViveSUP3192BLKS2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071315509TrendOrthofix US LLCIQQ2026-04-25
00850071315516TrendOrthofix US LLCIQQ2026-04-25
00850071315486TrendOrthofix US LLCIQQ2026-04-23
00850071315493TrendOrthofix US LLCIQQ2026-04-23
00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IQQ2025-10-03
08936235650005Fullerton Manufacturing LimitedFULLERTON MANUFACTURING LIMITEDIQQ2025-07-02
04719883461698TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463432TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463449TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463456TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463463TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464286TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464859TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464866TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464873TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464880TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
00810179880958CopperfitIdeavillage Products CorpIQQ2024-11-18
00810179880965CopperfitIdeavillage Products CorpIQQ2024-11-18
00850012035312Unite Medical®Unite Medical, LLCIQQ2024-06-20
00749756394734DeRoyalDEROYAL INDUSTRIES, INC.IQQ2024-06-06
50749756394739DeRoyalDEROYAL INDUSTRIES, INC.IQQ2024-06-06
04719883460165TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460523TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460554TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460608TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460622TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460660TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460714TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460745TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460912TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31