FDA.reportPublic FDA data

CosmoLock Pedicle Screw System

Primary DI
B07310NBN05600
Brand
CosmoLock Pedicle Screw System
Company
Kalitec Direct LLC
Model
10-NBN-0560
Device description
Guidewire, NiTi Blunt, Non-threaded, 560mm
Published
2018-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GDFGuide, Needle, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07310NBN05600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, reusableA long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
041956211
Device count
1
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344044801MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
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07630037864523APTUSMedartis AGGDF2025-04-08
07630037864547APTUSMedartis AGGDF2025-04-08
07630037864561APTUSMedartis AGGDF2025-04-08
07630037864585APTUSMedartis AGGDF2025-04-08
10197106342312CARDINAL HEALTHCardinal Health 200, LLCGDF2024-04-01
07630037864165APTUSMedartis AGGDF2024-03-22
ESAM14755481STOMA®Storz am Mark GmbHGDF2023-11-20
ESAM14760481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14761481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14750481STOMA®Storz am Mark GmbHGDF2022-11-07
ESAM14751481STOMA®Storz am Mark GmbHGDF2022-11-07
08033860028596BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860028602BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860030353BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
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10840199534200Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534217Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534224Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534231Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534248Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534255Needle HolderKOROS U.S.A., INC.GDF2022-08-01