FDA.reportPublic FDA data

LTJ

Primary DI
00810041626929
Brand
LTJ
Company
AzurMeds Inc.
Model
81004162692
Device description
LTJ Screw Holder
Published
2020-10-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041626929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041626929008100416269298100416269290810041626929

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). 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
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
00810158219625PRINCETONPrinceton Medical Group, Inc.HXK2026-04-22
00810158216778PRINCETONPrinceton Medical Group, Inc.HXK2026-04-20
09348811016249INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
B356DF410180American MedicalsAmerican MedicalsHXK2025-11-10
B7685135310Buxton BioMedicalBuxton Biomedical IncHXK2025-11-03
04052536007899neon3Ulrich GmbH & Co. KGHXK2025-11-03
00810158217454PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00810158217461PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00840314251268gSourceGSOURCE LLCHXK2025-09-21
10649111488146Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
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