FDA.reportPublic FDA data

AMDT Mini-Rail

Primary DI
00855967006479
Brand
AMDT Mini-Rail
Company
ARROWHEAD DE LLC
Model
1
Catalog number
M747
Device description
Bone Screw ø3.0 mm X 100mm long, 40mm thread
Published
2018-09-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00855967006479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855967006479008559670064798559670064790855967006479

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
901-853-4366INFO@ArrowheadDevices.com

Regulatory Flags#

DUNS number
054367577
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855967006004ARROW-LOK121-3535132016-03-23
00855967006011ARROW-LOK121-3535162016-03-23
00855967006028ARROW-LOK127-2535192016-03-23
00855967006035ARROW-LOK121-2535192016-03-23
00855967006042ARROW-LOK121-2535222016-03-23
00855967006059ARROW-LOK121-2535252016-03-23
00855967006066ARROW-LOK121-2535282017-02-18
00855967006073ARROW-LOK121-2535302016-03-23
00855967006080ARROW-LOK121-2535332016-03-23
00855967006097ARROW-LOK121-2535352016-03-23
00855967006110ARROW-LOK121-2535402016-03-23
00855967006127ARROW-LOK121-2535452016-03-23
00855967006134ARROW-LOK121-2535502016-03-23
00855967006141ARROW-LOK127-2535222016-03-23
00855967006158ARROW-LOK127-2535252016-03-23
00855967006165ARROW-LOK127-2535282016-03-23
00855967006172ARROW-LOK127-2535302016-03-23
00855967006189ARROW-LOK127-2535332016-03-23
00855967006196ARROW-LOK127-2535352016-03-23
00855967006394AMDT Mini-Rail1M7322018-09-10

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
08905892004605GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004612GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004629GPCGPC MEDICAL LIMITEDJDW2024-01-31
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
08720629950556ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
08720629950563ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
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