FDA.reportPublic FDA data

TruPWR Torque Limiting Attachment, 6 Nm

Primary DI
00857676008720
Brand
TruPWR Torque Limiting Attachment, 6 Nm
Company
Eca Medical Instruments
Model
228-TXRX-003
Catalog number
228-TXRX-003
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857676008720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857676008720008576760087208576760087200857676008720

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084330422
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)228-TXRX-006228-TXRX-0062026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)228-TXRX-007228-TXRX-0072026-06-05
00857676008911IM NAIL PERCUTANEOUS DEPTH GAUGE STERILE (1043)104310432026-04-02
00850078396105IM NAIL DISPOSABLE HANDLE STERILE (1044)104410442026-03-10
00857676008812IM NAIL FRACTURE REDUCTION GUIDE STERILE (1012)10122025-06-17
00857676008874TruTORQ Medium Axial Handle, Sterile, Single Use, With T8101010102026-02-25
00850078396082TruPWR Torque Limiting Attachment Sterile, Single Use 11.3Nm228-TXRX-005228-TXRX-0052026-02-04
00850078396129TransLoc 3D, Depth Gauge for All-Metal Introducer103010302026-01-21
00850078396136iFuse INTRA Ti Instrument Kit102910292026-01-12
00850078396143Invictus Power FT, 110in-lb/12.4Nm228-TXRX-004228-TXRX-0042026-01-05
00850078396075Arsenal Foot™ Bone Harvesting Kit, Ø 8.0mm104010402025-12-18
00850078396280TRAQ Single Use Instrument Kit104210422025-12-12
008576760089284.0, 3.5, 2.5 - ACUTRAK 3 MIS BUNION INSTRUMENT KIT (1028-001)1028-0011028-0012025-11-11
008576760089353.6/4.5mm - INnate Instrument Kit (1028-002)1028-0021028-0022025-11-11
00857676008942 2.0 - ACUTRAK 3 NANO INSTRUMENT KIT (1027-001)1027-0011027-0012025-11-11
008576760089592.5 - ACUTRAK 3 MICRO INSTRUMENT KIT (1027-002)1027-0021027-0022025-11-11
008576760089663.5 - ACUTRAK 3 MINI INSTRUMENT KIT (1027-003)1027-0031027-0032025-11-11
008576760089734.0 - ACUTRAK 3 STANDARD INSTRUMENT KIT (1027-004)1027-0041027-0042025-11-11
008576760089803.6 mm - INNATE INSTRUMENT KIT(1027-005)1027-0051027-0052025-11-11
008576760089974.5 mm - INNATE INSTRUMENT KIT (1027-006)1027-0061027-0062025-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)Eca Medical InstrumentsHWE2026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)Eca Medical InstrumentsHWE2026-06-05
10705034647807TRIALTISMedos International SàrlHWE2026-06-03
10705034647814TRIALTISMedos International SàrlHWE2026-06-03
10705034647821TRIALTISMedos International SàrlHWE2026-06-03
10705034647838TRIALTISMedos International SàrlHWE2026-06-03
10705034648118TRIALTISMedos International SàrlHWE2026-06-03
00810111227292K-WireTreace Medical Concepts, Inc.HWE2026-06-02
07613327648331PANGEAStryker GmbHHWE2026-06-02
07613327648362PANGEAStryker GmbHHWE2026-06-02
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652789N/ASTRYKER CORPORATIONHWE2026-03-25
07640187462302Power Tool TL Attachment 2.5mmBonebridge AGHWE2025-10-17
07613327649161T2, PANGEAStryker GmbHHWE2025-09-25
07613327566000T2 ALPHAStryker GmbHHWE2024-03-01
07613327566055T2 ALPHAStryker GmbHHWE2024-03-01
07613327566079T2 ALPHAStryker GmbHHWE2024-03-01
07613327538939Prep PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539332Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539349Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539448Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327542134Bone Mill PlusSTRYKER CORPORATIONHWE2022-12-22
07613327467765EZoutSTRYKER CORPORATIONHWE2021-06-17
07613327467864PrecisionSTRYKER CORPORATIONHWE2021-06-17
07613327467819NASTRYKER CORPORATIONHWE2021-06-15
07613327467826NASTRYKER CORPORATIONHWE2021-06-15
07613327467833NASTRYKER CORPORATIONHWE2021-06-15
07613327467840NASTRYKER CORPORATIONHWE2021-06-15
07613327467857NASTRYKER CORPORATIONHWE2021-06-15