FDA.report

EZX

Primary DI
08800038053182
Brand
EZX
Company
IMEDICOM CO., LTD.
Model
XZT1000
Device description
EZX Sterilization Tray
Published
2022-03-11
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications

CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800038053182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800038053182088000380531828800038053182

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
690340653
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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08800038060340EZImpactorBMA-P20-S012026-01-22
08800038029323SteriSpine VA KITKYPHO102025-09-24
08800038029330SteriSpine VA KITKYPHO152025-09-24
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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
08800038039438SteriSpine VA SPICD-CA2/ SPICD-NDD22025-09-24
08800038039445SteriSpine VA SPICD-SP12025-09-24
08800038039452SteriSpine VA SPICD-BI1/ SPICD-BIC12025-09-24
08800038039469SteriSpine VA SPICD-CP1/ SPICD-CF12025-09-24
08800038039476SteriSpine VA SPICD-CP1/ SPICD-CFS12025-09-24

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09421038412169Offset drive train, lockingENZTEC LIMITEDHWE2026-03-09
09421038412176Short Offset Cover – UnitedENZTEC LIMITEDHWE2026-03-09
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09421038412305Offset coupling, AOENZTEC LIMITEDHWE2026-03-09
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00810111225601ReamerTreace Medical Concepts, Inc.HWE2026-03-02
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