FDA.reportPublic FDA data

SM K-WIRES

Primary DI
00887919719960
Brand
SM K-WIRES
Company
Peter Brasseler Holdings, LLC
Model
5004220M1
Catalog number
KM173-39-45S
Device description
"KM173-39-45S TH SM K-WIRE .045"""
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDWPIN, FIXATION, THREADED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919719960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919719960008879197199608879197199600887919719960

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535023398Brasseler USA5031885U05031885U02026-05-13
08404535029406Brasseler USA5032304U05032304U02026-05-13
08404535029437Brasseler USA5032305U05032305U02026-05-13
08404535025101Brasseler USA5032020U05032020U02026-05-11
08404535025927Brasseler USA5032032U05032032U02026-05-01
08404535015003Brasseler USA5031791U05031791U02026-04-29
08404535015126Brasseler USA5031795U05031795U02026-04-29
08404535018929Brasseler USA5031818U05031818U02026-04-29
08404535018950Brasseler USA5031819U05031819U02026-04-29
08404535019049Brasseler USA5031822U05031822U02026-04-29
08404535019070Brasseler USA5031823U05031823U02026-04-29
08404535019100Brasseler USA5031824U05031824U02026-04-29
08404535019131Brasseler USA5031825U05031825U02026-04-29
08404535019162Brasseler USA5031826U05031826U02026-04-29
08404535024227Axiom BladesBRAXM-GP8BRAXM-GP82026-04-29
08404535024258Axiom BladesBRAXM-FP14MBRAXM-FP14M2026-04-29
08404535024289Axiom BladesBRAXM-FC6BRAXM-FC62026-04-29
08404535024319Axiom BladesBRAXM-FP8SBRAXM-FP8S2026-04-29
08404535024340Axiom BladesBRAXM-HP8SBRAXM-HP8S2026-04-29
08404535024371Axiom BladesBRAXM-HP8MBRAXM-HP8M2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059386747407DOLPHIXCITIEFFE SRLJDW2025-04-02
08052990971893DOLPHIXCITIEFFE SRLJDW2024-10-28
08032909624256ST.A.R. 90 F4CITIEFFE SRLJDW2024-09-11
08905892004599GPCGPC MEDICAL LIMITEDJDW2024-01-31
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08905892004636GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004643GPCGPC MEDICAL LIMITEDJDW2024-01-31
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08905892004667GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004674GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004704GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004711GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004728GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004735GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004742GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004759GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004766GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004773GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004780GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004568GPCGPC MEDICAL LIMITEDJDW2023-12-30
08905892004575GPCGPC MEDICAL LIMITEDJDW2023-12-30
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