DEVICE: OXFORD ANKLE FUSION NAIL(AFN) SYSTEM (05055662944761)

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Device Identifier (DI) Information

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
OS333013
OS333013
ORTHO SOLUTIONS HOLDINGS LIMITED
05055662944761
GS1
1
OXBRIDGE AFN DISPOSABLES - DRILLS / PIN & EXCHANGE TUBE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
Yes
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Joint prosthesis implantation kit, single-use A collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 29, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+441621843599
quality@orthosol.com
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