FDA.reportPublic FDA data

EnFix Instrument Kit - TAC

Primary DI
00860015151322
Brand
EnFix Instrument Kit - TAC
Company
TETROUS, INC.
Model
TET-KT-006
Published
2026-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
HWJAwl
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
HWJAwlOrthopedic1
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015151322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015151322008600151513228600151513220860015151322

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
111821928
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014213489GuidewireTET-INS-0212026-02-24
00860015151308EnFix Instrument Kit - CompleteTET-KT-0042026-02-24
00860015151315EnFix Instrument Kit - ACLTET-KT-0052026-02-24
00860014213427Awl - Non-CuttingTET-INS-0112026-02-10
00860014213434Cutting Awl - 5.5mmTET-INS-0122026-02-10
00860014213441Cutting Awl - 4.5mmTET-INS-0132026-02-10
00860014213458Introducer ProbeTET-INS-0142026-02-10
00860014213465Instrument TrayTET-INS-0162026-02-10
00860014213472Pusher ProbeTET-INS-0202026-02-10
00860014213496Introducer Probe - SJTET-INS-0072026-02-10
00860014213403Introducer Probe - Flat CollarTET-INS-0052025-11-04
00860014213410Introducer Probe - Stepped CollarTET-INS-0042025-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
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07630894802973APTUSMedartis AGFSM2023-02-24
07630894802980APTUSMedartis AGFSM2023-02-24
07630894802997APTUSMedartis AGFSM2023-02-24
07630894803208APTUSMedartis AGFSM2023-02-24
07630894803215APTUSMedartis AGFSM2023-02-24
07630894803222APTUSMedartis AGFSM2023-02-24
07630894803246APTUSMedartis AGFSM2023-02-24
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07630894803307APTUSMedartis AGFSM2023-02-24
07630894803314APTUSMedartis AGFSM2023-02-24
07630894803321APTUSMedartis AGFSM2023-02-24
07630894803338APTUSMedartis AGFSM2023-02-24
07630894803345APTUSMedartis AGFSM2023-02-24
07630894803369APTUSMedartis AGFSM2023-02-24
07630894803383APTUSMedartis AGFSM2023-02-24