DEVICE: Fixion Nailing System (07290109330198)

Device Identifier (DI) Information

Fixion Nailing System
Humeral Nail
In Commercial Distribution
1113528
CARBOFIX ORTHOPEDICS LTD
07290109330198
GS1

1
649185170 *Terms of Use
The nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal. 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

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38153 Humerus nail
A rod made of metal or other material intended to be implanted into the intramedullary canal of the humerus to immobilize 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. 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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
JDS Nail, Fixation, Bone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 280 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: 10.7 Millimeter
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Device Record Status

c8fd445d-ede3-4252-8928-350c6753f00e
December 08, 2022
3
October 19, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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