DEVICE: FASSIER-DUVAL TELESCOPIC IM SYSTEM (07540194000354)

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Device Identifier (DI) Information

FASSIER-DUVAL TELESCOPIC IM SYSTEM
FD-040(SPS)-SS
FD-040(SPS)-SS
Pega Medical Inc
07540194000354
GS1
1
Short Tibial/Humeral Nail Assy Ø4.0mm x 333mm
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Humerus nail, sterile A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the humerus, 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. 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.
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.
Femur nail, sterile A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, 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

[?]
Product Code Product Code Name
HSB ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: keep at room temperature
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 4 Millimeter
Length: 333 Millimeter
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Device Status

In Commercial Distribution
October 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
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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(450)688-5144 242
egarcia@pegamedical.com
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