FDA.reportPublic FDA data

LexBLADE

Primary DI
04589761818056
Brand
LexBLADE
Company
MEDMETALEX CO., LTD.
Model
MUA00056
Catalog number
MUA00056
Device description
LexBLADE Single-Edge Chisel, W12/16°/L23cm
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZOChisel, Surgical, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589761818056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589761818056045897618180564589761818056

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
718085432
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589761815826LexCALIPERMUA00050MUA000502023-03-31
04589761818001LexTORNADOMUA00051MUA000512023-10-02
04589761818018LexTORNADOMUA00052MUA000522023-10-02
04589761815789LexTOMEMUA00046MUA000462023-04-24
04589761818025LexBLADEMUA00053MUA000532023-10-02
04589761818032LexBLADEMUA00054MUA000542023-10-02
04589761818049LexBLADEMUA00055MUA000552023-10-02
04589761818063LexBLADEMUA00057MUA000572023-10-02
04589761818070LexBLADEMUA00058MUA000582023-10-02
04589761818087LexBLADEMUA00059MUA000592023-10-02
04589761818094LexBLADEMUA00060MUA000602023-10-02
04589761818100LexBLADEMUA00061MUA000612023-10-02
04589761818117LexBLADEMUA00062MUA000622023-10-02
04589761818124LexBLADEMUA00063MUA000632023-10-02
04589761818131LexBLADEMUA00064MUA000642023-10-02
04589761818346quick armMUA00065MUA000652023-10-02
04589761818353quick armMUA00066MUA000662023-10-02
04589761818360quick armMUA00067MUA000672023-10-02
04589761818377quick armMUA00068MUA000682023-10-02
04589761818384quick arm MUA00069MUA000692023-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806373887697BENCOX Surgical InstrumentsCorentec Co., LtdFZO2026-04-10
10649111080036Sklar®SKLAR CORPORATIONFZO2019-02-25
10649111010613Sklar®SKLAR CORPORATIONFZO2019-02-12
10649111052699Sklar®SKLAR CORPORATIONFZO2018-11-26
10381780495215Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-24
10381780495314Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-24
10381780509325Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-23
10649111066283Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111066733Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067198Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067556Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067938Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111068317Sklar®SKLAR CORPORATIONFZO2018-10-22
10381780506874Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-17
10649111095245Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095443Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095559Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095825Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096013Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096112Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096341Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096556Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096679Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096822Sklar®SKLAR CORPORATIONFZO2018-09-27
10603295084020SIGMADEPUY (IRELAND)FZO2018-09-24
10603295107798NADEPUY ORTHOPAEDICS, INC.FZO2018-09-24
10603295122715NADEPUY (IRELAND)FZO2018-09-24
10381780499176Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18
10381780499183Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18
10381780499190Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18