DEVICE: NA (10705034460543)

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Device Identifier (DI) Information

NA
698339724
698339724
DEPUY SPINE, LLC
10705034460543
GS1
1
MODIFIED INSTRUMENT MODIFIED SPACER BLOCK 9mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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 implant aiming/guiding block A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes of various sizes and shapes in it used by the surgeon to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of high-grade stainless steel or synthetic materials and will typically have a connecting bolt in its centre for attachment to the implant. The surgeon can ascertain the correct placement of the implant and that the bone screws used to fix the plate in place are at the correct angle to the anatomy of the bone. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
November 18, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+1(800)255-2500
xx@xx.xx
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