FDA.reportPublic FDA data

LexCALIPER

Primary DI
04589761815826
Brand
LexCALIPER
Company
MEDMETALEX CO., LTD.
Model
MUA00050
Catalog number
MUA00050
Device description
Femoral Head Diameter Caliper
Published
2023-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589761815826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589761815826045897618158264589761815826

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head prosthesis trialA copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

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
04589761818001LexTORNADOMUA00051MUA000512023-10-02
04589761818018LexTORNADOMUA00052MUA000522023-10-02
04589761815789LexTOMEMUA00046MUA000462023-04-24
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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