DEVICE: FASSIER-DUVAL TELESCOPIC IM SYSTEM (07540194000422)
Device Identifier (DI) Information
FASSIER-DUVAL TELESCOPIC IM SYSTEM
FDLON-F048-SS
In Commercial Distribution
FDLON-F048-SS
Pega Medical Inc
FDLON-F048-SS
In Commercial Distribution
FDLON-F048-SS
Pega Medical Inc
LON Femoral Nail Assy Ø4.8 mm x 400mm
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 |
---|---|
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. |
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. |
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: 4.8 Millimeter |
Length: 400 Millimeter |
Device Record Status
89628d96-fbf0-4383-a2c0-802cd608a1a2
July 06, 2018
3
October 20, 2016
July 06, 2018
3
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