FDA.reportPublic FDA data

EZX

Primary DI
08800038060296
Brand
EZX
Company
IMEDICOM CO., LTD.
Model
XTR2-003
Device description
EZX (Upper Tray)
Published
2025-07-17
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800038060296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800038060296088000380602968800038060296

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690340653
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
08800038060807EZImpactorBMA-P20-IW12026-04-21
08800038060814EZImpactorBMA-P20-SW12026-04-21
08800038060784EZImpactorBMA-P10-IW12026-04-01
08800038060791EZImpactorBMA-P10-SW12026-04-01
08800038060319EZImpactorBMA-P10-I012026-01-22
08800038060326EZImpactorBMA-P10-S012026-01-22
08800038060333EZImpactorBMA-P20-I012026-01-22
08800038060340EZImpactorBMA-P20-S012026-01-22
08404535020120Brasseler EZXBRXTR2-0012025-10-10
08800038029323SteriSpine VA KITKYPHO102025-09-24
08800038029330SteriSpine VA KITKYPHO152025-09-24
08800038029347SteriSpine VA KITKYPHO202025-09-24
08800038029354SteriSpine VA KITKYPHO10B2025-09-24
08800038029361SteriSpine VA KITKYPHO15B2025-09-24
08800038029378SteriSpine VA KITKYPHO20B2025-09-24
08800038029415SteriSpine VA SPICD-CA2/ SPICD-NDB22025-09-24
08800038029422SteriSpine VA SPICD-CA2/ SPICD-NDT22025-09-24
08800038039407SteriSpine VA SPICD-CA1/ SPICD-NDB12025-09-24
08800038039414SteriSpine VA SPICD-CA1/ SPICD-NDD12025-09-24
08800038039421SteriSpine VA SPICD-CA1/ SPICD-NDT12025-09-24

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