DEVICE: FASSIER-DUVAL TELESCOPIC IM SYSTEM (07540194000279)
Device Identifier (DI) Information
FASSIER-DUVAL TELESCOPIC IM SYSTEM
FD-032(S)-SS
In Commercial Distribution
FD-032(S)-SS
Pega Medical Inc
FD-032(S)-SS
In Commercial Distribution
FD-032(S)-SS
Pega Medical Inc
Short Femoral Nail Assy Ø3.2 mm
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
38152 | Tibia nail |
A rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia 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, 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.
|
Active | true |
33187 | Femur nail |
A rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.
|
Active | true |
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K020885 | 000 |
K041393 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: keep at room temperature |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 3.2 Millimeter |
Length: 197 Millimeter |
Device Record Status
98e18259-93f9-420b-9db1-c9de15979522
December 08, 2022
5
October 20, 2016
December 08, 2022
5
October 20, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(450)688-5144
242
egarcia@pegamedical.com
egarcia@pegamedical.com