FDA.reportPublic FDA data

TITANEX

Primary DI
00841731152015
Brand
TITANEX
Company
VILEX LLC
Model
TU-HDFT-40-TRY
Device description
TITANEX ULTRA 4.0mm Headed Fully Threaded Tray
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250304000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250304000TITANEX Screw SystemsVilex, LLC2025-03-05HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731152015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731152015008417311520158417311520150841731152015

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)521-5002info@vilex.com

Regulatory Flags#

DUNS number
117502293
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731140395ARTEMIS FUZEAV40-20T-16V2026-07-22
00841731140401ARTEMIS FUZEAV40-22T-16V2026-07-22
00841731140418ARTEMIS FUZEAV40-24T-16V2026-07-22
00841731140425ARTEMIS FUZEAV40-26T-16V2026-07-22
00841731140432ARTEMIS FUZEAV40-28T-16V2026-07-22
00841731140449ARTEMIS FUZEAV40-30T-16V2026-07-22
00841731140456ARTEMIS FUZEAV40-32T-16V2026-07-22
00841731140463ARTEMIS FUZEAV40-34T-16V2026-07-22
00841731140470ARTEMIS FUZEAV40-36T-16V2026-07-22
00841731140487ARTEMIS FUZEAV40-38T-16V2026-07-22
00841731140494ARTEMIS FUZEAV40-40T-16V2026-07-22
00841731140500ARTEMIS FUZEAV40-42T-16V2026-07-22
00841731140517ARTEMIS FUZEAV40-44T-16V2026-07-22
00841731140524ARTEMIS FUZEAV40-46T-16V2026-07-22
00841731140531ARTEMIS FUZEAV40-48T-16V2026-07-22
00841731140548ARTEMIS FUZEAV40-50T-16V2026-07-22
00841731140555ARTEMIS FUZEAV40-52T-16V2026-07-22
00841731140562ARTEMIS FUZEAV40-54T-16V2026-07-22
00841731140593ARTEMIS FUZEAV30-16T-11V2026-07-22
00841731140609ARTEMIS FUZEAV30-18T-11V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376778372InvictusALPHATEC SPINE, INC.FSM2026-08-19
00190376778396InvictusALPHATEC SPINE, INC.FSM2026-08-19
08800322759516Torque Limiting HandleGS Medical Co., Ltd.FSM2026-08-18
10806378116810ACUMEDAcumed LLCFSM2026-08-18
10806378116827ACUMEDAcumed LLCFSM2026-08-18
10806378116841ACUMEDAcumed LLCFSM2026-08-18
10806378116858ACUMEDAcumed LLCFSM2026-08-18
G8791062750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107193L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107193S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107241S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072790DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G8791072800DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879107280S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC05S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC07S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC10F0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC10S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC20A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC20F0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
G879SC21N0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18
03700879517803airlock®NOVASTEPFSM2026-08-17