FDA.reportPublic FDA data

TEHLIN

Primary DI
04719883460028
Brand
TEHLIN
Company
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
Model
A-TGK-4001
Device description
GRAPH-LITE 4 BAR KNEE WITH MANUAL LOCK
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
ISYJoint, Knee, External Limb Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISYJoint, Knee, External Limb ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719883460028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719883460028047198834600284719883460028

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657485074
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
04719883460035TEHLINA-TGK-40022023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850092871008Bio Leg 2™BIONICM INC.ISY2026-11-01
00850092871015Bio Leg 2™BIONICM INC.ISY2026-11-01
00850092871022Bio Leg 2™BIONICM INC.ISY2026-11-01
00850092871039Bio Leg 2™BIONICM INC.ISY2026-11-01
00860010894866ASISTA™BIONICM INC.ISY2026-11-01
00860010894873ASISTA™BIONICM INC.ISY2026-11-01
00860010894880ASISTA™BIONICM INC.ISY2026-11-01
00860010894897ASISTA™BIONICM INC.ISY2026-11-01
00195411012053IconCOLLEGE PARK INDUSTRIES, INC.ISY2026-10-01
00841747186936Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00841747186943Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00195411458905IconCOLLEGE PARK INDUSTRIES, INC.ISY2025-05-28
00194711121014IntuyWillowwood Global LLCISY2025-03-21
00194711121021IntuyWillowwood Global LLCISY2025-03-21
00713980034377BIOSTEP XTAlps South, LLCISY2025-01-14
04719883460356TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
04719883460370TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
00195411458820IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458837IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458844IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458851IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458868IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00841747186707AuraCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
04719883460004TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460035TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460059TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460066TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460073TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460103TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460110TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31