DEVICE: ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS (05055662903072)

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Device Identifier (DI) Information

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
OS246580
OS246580
ORTHO SOLUTIONS HOLDINGS LIMITED
05055662903072
GS1
1
SELF-DRILL SCHANZ SCREW 5.0MM, LENGTH 200MM, THREAD 80MM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
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
Orthopaedic bone screw, non-bioabsorbable, sterile A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.
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FDA Product Code

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Product Code Product Code Name
HWC Screw, Fixation, Bone
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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
May 20, 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
05055662903065 5 05055662903072 In Commercial Distribution Cardboard Box
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+441621843599
quality@orthosol.com
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