FDA.reportPublic FDA data

TEHLIN

Primary DI
04719883460165
Brand
TEHLIN
Company
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
Model
H-TFC-DFML
Device description
EVA-LAST COSMETIC COVER, MEDIUM / LEFT
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
04719883460165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719883460165047198834601654719883460165

GMDN Terms#

Term, Definition table
TermDefinition
External lower-limb prosthesis structural/alignment componentA component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint prosthesis]; and/or 2) an alignment element to enable adjustment of the orientation of the prosthesis components relative to each other and to the patient (e.g., mediolateral shift, anteroposterior tilt). It may be in the form of a tube, pylon, adaptor, attachment block, clamp, pyramid, socket anchor, plate, or other design, and is intended to remain an integral part of the fitted prosthesis.

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