EZX Blade

GUDID 08800038035324

IMEDICOM CO., LTD.

Sagittal surgical saw blade, single-use
Primary Device ID08800038035324
NIH Device Record Keydd411d73-d246-4266-933b-0972eba54b6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZX Blade
Version Model NumberBRXTB560
Company DUNS690340653
Company NameIMEDICOM CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800038035324 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-11
Device Publish Date2019-08-28

On-Brand Devices [EZX Blade]

08800038035423BRXTB460
08800038035416BRXTB470
08800038035409BRXTB480
08800038035393BRXTB490
08800038035386BRXTB500
08800038035379BRXTB510
08800038035362BRXTB520
08800038035355BRXTB530
08800038035348BRXTB540
08800038035331BRXTB550
08800038035324BRXTB560
08800038035317BRXTB570
08800038035300BRXTB580
08800038035294BRXTB590
08800038035287BRXTB600
08800038035270BRXTB610
08800038035263BRXTB620
08800038035256BRXTB630
08800038035249BRXTB640
08800038035232BRXTB650
08800038035225BRXTB660
08800038035218BRXTB670
08800038035201BRXTB680
08800038035195BRXTB690
08800038035188BRXTB700
08800038035171BRXTB710
08800038035164BRXTB720
08800038035157BRXTB730
08800038035140BRXTB740

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