EZX

GUDID 08800038032156

IMEDICOM CO., LTD.

Sawing power tool attachment, sagittal
Primary Device ID08800038032156
NIH Device Record Keyd1f48405-1e7e-4fba-8783-7e02ab94db87
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZX
Version Model NumberEZX Kit 15
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800038032156 [Primary]

FDA Product Code

GFABlade, Saw, General & Plastic Surgery, Surgical
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800038032156]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-11
Device Publish Date2019-05-09

On-Brand Devices [EZX]

08800038032408XST2000 PLUS
08800038032392XST1000B
08800038032385XST1000A
08800038032378XTL65B
08800038032361XTL64B
08800038032354XTL63B
08800038032347XTL62B
08800038032330XTL61B
08800038032323XTL60B
08800038032316XTL59B
08800038032309XTL58B
08800038032293XTL65A
08800038032286XTL64A
08800038032279XTL63A
08800038032262XTL62A
08800038032255XTL61A
08800038032248XTL60A
08800038032231XTL59A
08800038032224XTL58A
08800038032217EZS101
08800038032200EZX511
08800038032194EZX501
08800038032187EZX Kit 18
08800038032170EZX Kit 17
08800038032163EZX Kit 16
08800038032156EZX Kit 15
08800038032149EZX Kit 14
08800038032132EZX Kit 13
08800038032125EZX Kit 12
08800038032118EZX Kit 11
08800038032101EZX Kit 10
08800038032095EZX Kit 09
08800038033061XTLSB5865
08800038033054XTLSA5865
08800038033047XTLSB3765
08800038033030XTLSA3765
08800038033023XTLSB3757
08800038033016XTLSA3757
08809544171731EZX500
08800038035973BR EZX Kit 28
08800038035966BR EZX Kit 27
08800038035959BR EZX Kit 26
08800038035942BR EZX Kit 25
08800038035935BR EZX Kit 24
08800038035928BR EZX Kit 23
08800038035911BR EZX Kit 22
08800038035904BR EZX Kit 21
08800038035898BR EZX Kit 20
08800038035881BR EZX Kit 19
08800038035874EZX Kit 28

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