LexBLADE MUA00058

GUDID 04589761818070

LexBLADE Single-Edge Chisel, W20/16°/L23cm

MEDMETALEX CO., LTD.

Orthopaedic chisel
Primary Device ID04589761818070
NIH Device Record Key17d4634c-161d-46c9-a9f0-6f396b26b3e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameLexBLADE
Version Model NumberMUA00058
Catalog NumberMUA00058
Company DUNS718085432
Company NameMEDMETALEX 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104589761818070 [Primary]

FDA Product Code

FZOChisel, Surgical, Manual

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


[04589761818070]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-10
Device Publish Date2023-10-02

On-Brand Devices [LexBLADE]

04589761818131LexBLADE Offset Chisel W18/L23cm
04589761818124LexBLADE Double-Edge Chisel, W20/L23cm
04589761818117LexBLADE Double-Edge Chisel, W15/L23cm
04589761818100LexBLADE Double-Edge Chisel, W12/L23cm
04589761818094LexBLADE Double-Edge Chisel, W10/L23cm
04589761818087LexBLADE Double-Edge Chisel, W8/L23cm
04589761818070LexBLADE Single-Edge Chisel, W20/16°/L23cm
04589761818063LexBLADE Single-Edge Chisel, W15/16°/L23cm
04589761818056LexBLADE Single-Edge Chisel, W12/16°/L23cm
04589761818049LexBLADE Single-Edge Chisel, W10/16°/L23cm
04589761818032LexBLADE Single-Edge Chisel, W8/16°/L23cm
04589761818025LexBLADE Single-Edge Chisel, W7/16°/L23cm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.