FDA.reportPublic FDA data

Medical Facets NC

Primary DI
M933MDF292680
Brand
Medical Facets NC
Company
MEDICAL FACETS NC LLC
Model
MDF292680
Catalog number
MDF-292-680
Device description
2.8mm Guidewire, threaded tip, 300mm
Published
2017-02-02
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
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M933MDF292680PrimaryHIBCC0

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
061276724
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
M933MDF022260100Medical Facets NCMDF02226010MDF022260102015-10-12
M933MDF022260110Medical FacetsMDF02226011MDF022260112015-10-12
M933MDF022260120Medical Facets NCMDF-02-226-012MDF-02-226-0122015-10-09
M933MDF022260130Medical Facets NCMDF-02-226-013MDF-02-226-0132015-10-09
M933MDF022260140Medical Facets NCMDF-02-226-014MDF-02-226-0142015-10-09
M933MDF022260150Medical Facets NCMDF-02-226-015MDF-02-226-0152015-10-09
M933MDF022260160Medical Facets NCMDF-02-226-016MDF-02-226-0162015-10-09
M933MDF022260170Medical Facets NCMDF-02-226-017MDF-02-226-0172015-10-09
M933MDF022260180Medical Facets NCMDF-02-226-018MDF-02-226-0182015-10-09
M933MDF022260190Medical Facets NCMDF-02-226-019MDF-02-226-0192015-10-09
M933MDF022260200Medical Facets NCMDF-02-226-020MDF-02-226-0202015-10-09
M933MDF022260210Medical Facets NCMDF-02-226-021MDF-02-226-0212015-10-09
M933MDF022260220Medical Facets NCMDF-02-226-022MDF-02-226-0222015-10-09
M933MDF022260230Medical Facets NCMDF-02-226-023MDF-02-226-0232015-10-09
M933MDF022260240Medical Facets NCMDF-02-226-024MDF-02-226-0242015-10-09
M933MDF022260250Medical Facets NCMDF-02-226-025MDF-02-226-0252015-10-09
M933MDF022260260Medical Facets NCMDF-02-226-026MDF-02-226-0262015-10-09
M933MDF022260270Medical Facets NCMDF-02-226-027MDF-02-226-0272015-10-09
M933MDF022260280Medical Facets NCMDF-02-226-028MDF-02-226-0282015-10-09
M933MDF022260290Medical Facets NCMDF-02-226-029MDF-02-226-0292015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
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06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
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07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
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