FDA.reportPublic FDA data

Kalitec Universal Instruments

Primary DI
B07301K1284520
Brand
Kalitec Universal Instruments
Company
Kalitec Direct LLC
Model
01-K12-8452
Catalog number
01-K12-8452
Device description
Tube, Guidewire, 520MM
Published
2019-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXIPasser, Wire, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07301K1284520PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. 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
041956211
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
B073DRK0100300CosmolockDR-K01-0030DR-K01-00302021-03-16
B073K0730000Matira07-K07-300007-K07-30002020-01-03
B07307CPR01181Matira Anterior Cervical Plate System07-CPR-011807-CPR-01182017-10-31
B07307CPR01191MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-011907-CPR-01192017-10-31
B07307CPR01201MATIRA ANTERIOR CERVICAL PLATE SYSTEM07-CPR-012007-CPR-01202017-10-31
B07307CPR01211MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012101-CPR-01212017-10-31
B07307CPR01221MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012207-CPR-01222017-10-31
B07307CPR01241MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012407-CPR-01242017-10-31
B07307CPR01261MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012607-CPR-01262017-10-31
B07307CPR01281MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012807-CPR-01282017-10-31
B07307CPR01301MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-013007-CPR-01302017-10-31
B07307CPR01321MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-013207-CPR-01322017-10-31
B07307CPR01341MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-013407-CPR-01342017-10-31
B07307CPR02321MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023207-CPR-02322017-10-31
B07307CPR02341MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023407-CPR-02342017-10-31
B07307CPR02361MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023607-CPR-02362017-10-31
B07307CPR02381MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023807-CPR-02382017-10-31
B07307CPR02401MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-024007-CPR-02402017-10-31
B07307CPR02421MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-024207-CPR-02422017-10-31
B07307CPR02441MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-024407-CPR-02442017-10-31

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