DEVICE: Fixion Nailing System (07290109330969)

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Device Identifier (DI) Information

Fixion Nailing System
Interlocking Tibial Nail
2213540
CARBOFIX ORTHOPEDICS LTD
07290109330969
GS1
1
The interlocking intramedullary nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones. Includes nail cap.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Tibia nail, sterile A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. 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
Length: 400 Millimeter
Device Size Text, specify: Insertion Diameter: 8.5 Millimeter
Device Size Text, specify: Expanded Diameter: 13.5 Millimeter
Device Size Text, specify: Proximal Diameter: 10.5 Millimeter
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Device Status

In Commercial Distribution
October 20, 2015

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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
Yes
No
No CLOSE

Customer Contact

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+97299511511
info@carbo-fix.com
1-800-408-0120
usa@carbo-fix.com
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