FDA.reportPublic FDA data

EZX Blade

Primary DI
08800038035379
Brand
EZX Blade
Company
IMEDICOM CO., LTD.
Model
BRXTB510
Published
2019-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800038035379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800038035379088000380353798800038035379

GMDN Terms#

Term, Definition table
TermDefinition
Sagittal surgical saw blade, single-useA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with the cutting teeth arranged in an arc at the distal end pointing directly forward. It cuts when the blade is powered in a rapid oscillating (side to side) movement. This type of blade allows a frontal cutting action to be applied within a restricted area. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690340653
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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

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00842078134115CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
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10705034647807TRIALTISMedos International SàrlHWE2026-06-03
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