FDA.reportPublic FDA data

Invictus Power FT, 110in-lb/12.4Nm

Primary DI
00850078396143
Brand
Invictus Power FT, 110in-lb/12.4Nm
Company
Eca Medical Instruments
Model
228-TXRX-004
Catalog number
228-TXRX-004
Published
2026-01-05
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
00850078396143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078396143008500783961438500783961430850078396143

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
008500783961982.2 TITAN Nail Instrument KitF15-A-2784S1047-0012026-06-23
008500783962043.0 TITAN Nail Instrument KitF15-A-2884S1047-0022026-06-23
008500783962284.0 TITAN Nail Instrument KitF15-A-8004.30S1047-0032026-06-23
008500783962352.2-4.0 TITAN Nail SizerF15-A-2084S10482026-06-23
008500783962422.2 TITAN Nail Accessory KitF15-A-2785S1049-0012026-06-23
008500783962593.0 TITAN Nail Accessory KitF15-A-2885S1049-0022026-06-23
008500783962734.0 TITAN Nail Accessory KitF15-A-8004.31S1049-0032026-06-23
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
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

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04589551366316P300-2S100NAKANISHI INC.HWE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HWE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
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00842078134115CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
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