DEVICE: FASSIER-DUVAL TELESCOPIC IM SYSTEM (07540194006073)

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Device Record History
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Device Identifier (DI) Information
FASSIER-DUVAL TELESCOPIC IM SYSTEM
FD-IMPLSET
In Commercial Distribution
FD-IMPLSET
Orthopediatrics Canada ULC
07540194006073
GS1

1
243298854 *Terms of Use
FULL IMPLANTS STERILIZATION CASE
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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 intramedullary nail
A rigid 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; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It 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 intramedullary nail
A rigid 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 is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). 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 intramedullary nail
A rigid 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; it may also be used to support the bone in the presence of a pathological condition. It 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
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K020885 000
K041393 000
No CLOSE

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

[?]
Size Type Text
No Device Sizes
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Device Record Status
95e6abcb-8f9d-4677-bc1f-78eb2d881c5d
May 13, 2025
4
December 12, 2018
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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

[?]
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)

[?]
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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