FDA.reportPublic FDA data

Diamond Orthopedic

Primary DI
B551DMD292618
Brand
Diamond Orthopedic
Company
DIAMOND ORTHOPEDIC, LLC
Model
DMD-292-618
Catalog number
DMD-292-618
Device description
Guide Wire 0.8 mm with double trocar tip, length 125mm
Published
2023-11-02
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
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B551DMD292618PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080596041
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B551DMD292624Diamond OrthopedicDMD-292-624DMD-292-6242023-11-02
B551DMD292721Diamond OrthopedicDMD-292-721DMD-292-7212023-11-02
B551DMDKIT125T05S0Diamond OrthopedicDMD-KIT-125T05-SDMD-KIT-125T05-S2023-11-02
B551DMDKIT150T10S0Diamond OrthopedicDMD-KIT-150T10-SDMD-KIT-150T10-S2023-11-02
B551DMDKIT150T15S0Diamond OrthopedicDMD-KIT-150T15-SDMD-KIT-150T15-S2023-11-02
B551DMD02226210S1Diamond OrthopedicDMD-02-226-210SDMD-02-226-210S2023-11-02
B551DMD02226212S1Diamond OrthopedicDMD-02-226-212SDMD-02-226-212S2023-11-02
B551DMD02226214S1Diamond OrthopedicDMD-02-226-214SDMD-02-226-214S2023-11-02
B551DMD02226216S1Diamond OrthopedicDMD-02-226-216SDMD-02-226-216S2023-11-02
B551DMD02226318S1Diamond OrthopedicDMD-02-226-318SDMD-02-226-318S2023-11-02
B551DMD02226320S1Diamond OrthopedicDMD-02-226-320SDMD-02-226-320S2023-11-02
B551DMD02226322S1Diamond OrthopedicDMD-02-226-322SDMD-02-226-322S2023-11-02
B551DMD02226324S1Diamond OrthopedicDMD-02-226-324SDMD-02-226-324S2023-11-02
B551DMD02226326S1Diamond OrthopedicDMD-02-226-326SDMD-02-226-326S2023-11-02
B551DMD02226328S1Diamond OrthopedicDMD-02-226-228SDMD-02-226-228S2023-11-02
B551DMD02226330S1Diamond OrthopedicDMD-02-226-330SDMD-02-226-330S2023-11-02
B551DMDTPS220010S1Diamond OrthopedicDMD-TPS-220-010SDMD-TPS-220-010S2023-11-02
B551DMDTPS220012S1Diamond OrthopedicDMD-TPS-220-012SDMD-TPS-220-012S2023-11-02
B551DMDTPS220014S1Diamond OrthopedicDMD-TPS-220-014SDMD-TPS-220-014S2023-11-02
B551DMDTPS220016S1Diamond OrthopedicDMD-TPS-220-016SDMD-TPS-220-016S2023-11-02

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