FDA.reportPublic FDA data

LexTOME

Primary DI
04589761815789
Brand
LexTOME
Company
MEDMETALEX CO., LTD.
Model
MUA00046
Catalog number
MUA00046
Device description
ACETABULAR REAMER STRAIGHT HANDLE
Published
2023-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589761815789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589761815789045897618157894589761815789

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
04589761818025LexBLADEMUA00053MUA000532023-10-02
04589761818032LexBLADEMUA00054MUA000542023-10-02
04589761818049LexBLADEMUA00055MUA000552023-10-02
04589761818056LexBLADEMUA00056MUA000562023-10-02
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

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