FDA.reportPublic FDA data

LTJ

Primary DI
00810041626301
Brand
LTJ
Company
AzurMeds Inc.
Model
81004162630
Device description
LTJ Drill Driver
Published
2022-01-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXIGuide, Drill, Ligament

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXIGuide, Drill, LigamentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041626301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041626301008100416263018100416263010810041626301

GMDN Terms#

Term, Definition table
TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
773 564 9324contact@azurmeds.us

Regulatory Flags#

DUNS number
117700483
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810041623300LTJ810041623302021-05-01
00810041623317LTJ810041623312021-05-01
00810041623324LTJ810041623322021-05-01
00810041623331LTJ810041623332021-05-01
00810041623348LTJ810041623342021-05-01
00810041623355LTJ810041623352021-05-01
00810041623362LTJ810041623362021-05-01
00810041623379LTJ810041623372021-05-01
00810041623409LTJ810041623402021-05-01
00810041623430LTJ810041623432021-05-01
00810041623508LTJ810041623502021-05-01
00810041623515LTJ810041623512021-05-01
00810041623522LTJ810041623522021-05-01
00810041623539LTJ810041623532021-05-01
00810041623546LTJ810041623542021-05-01
00810041623553LTJ810041623552021-05-01
00810041623560LTJ810041623562021-05-01
00810041623577LTJ810041623572021-05-01
00810041623607LTJ810041623602021-05-01
00810041623638LTJ810041623632021-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G453332321055BC010PEAK MEDICALPeak Medical Distribution Inc.LXI2026-05-06
00888867500884Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500907Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500938Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500976Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500990Arthrex®ARTHREX, INC.LXI2026-03-13
00840124521018PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-06-24
00840124519978PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519985PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520189PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520226PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520233PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520257PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520264PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520325PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520332PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519572PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519589PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519602PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519619PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519664PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519671PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519688PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519695PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519701PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519732PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519787PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519794PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519800PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519831PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15