FDA.reportPublic FDA data

TEHLIN

Primary DI
04719883460745
Brand
TEHLIN
Company
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
Model
D-TTC-15
Device description
"15"" CHILD'S TUBE"
Published
2023-10-31
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
04719883460745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719883460745047198834607454719883460745

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657485074
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
04719883460356TEHLINC-TK-4P01P2025-01-10
04719883460370TEHLINC-TK-50SO2025-01-10
04719883461698TEHLINF-TSF-FFH0126L2025-01-10
04719883463432TEHLING-TCS-RA352025-01-10
04719883463449TEHLING-TCS-RA382025-01-10
04719883463456TEHLING-TCS-RA412025-01-10
04719883463463TEHLING-TCS-SA412025-01-10
04719883463470TEHLINF-TGF-2RU26R2025-01-10
04719883463494TEHLINJ-HT-12RTR2025-01-10
04719883463500TEHLINJ-HT-005R2025-01-10
04719883463517TEHLINJ-HT-004R2025-01-10
04719883463524TEHLINJ-HT-002L2025-01-10
04719883463531TEHLINJ-HT-010L2025-01-10
04719883464286TEHLING-TCS-SA352025-01-10
04719883464859TEHLING-TCS-SB242025-01-10
04719883464866TEHLING-TCS-RB182025-01-10
04719883464873TEHLING-TCS-RB212025-01-10
04719883464880TEHLING-TCS-RB242025-01-10
04719883460004TEHLINA-TGH-012023-10-31
04719883460028TEHLINA-TGK-40012023-10-31

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
04719883460912TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883462343TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31