FDA.reportPublic FDA data

TEHLIN

Primary DI
04719883463524
Brand
TEHLIN
Company
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
Model
J-HT-002L
Device description
FUNCTIONAL PALM (LEFT/LARGE)
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRAHand, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRAHand, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719883463524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719883463524047198834635244719883463524

GMDN Terms#

Term, Definition table
TermDefinition
Partial-hand prosthesisAn artificial substitute for part of a missing hand designed to replace the appearance and/or some of the function of the hand part.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657485074
Device count
1
Premarket exempt
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
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
04719883460035TEHLINA-TGK-40022023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719883463494TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
04719883463500TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
04719883463517TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
04719883463531TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
00713980001331LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001348LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001355LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001362LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001379LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001386LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001393LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001409LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001416LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001423LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001430LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001447LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980004332LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980004615LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980005131LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980005148LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980005179LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980005384LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980006008LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980006015LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980006046LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980008620LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980008637LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980008644LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980008651LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980008668LOCK DEVICESAlps South, LLCIRA2024-12-30