DEVICE: One (00194711300952)
Device Identifier (DI) Information
One
ONE-TF-DISTAL-DUO-1
In Commercial Distribution
ONE-TF-DISTAL-DUO-1
Willowwood Global LLC
ONE-TF-DISTAL-DUO-1
In Commercial Distribution
ONE-TF-DISTAL-DUO-1
Willowwood Global LLC
WillowWood One TF System, Distal Mount LLVS 2 with Alpha Duo Liner Kit, Medium Plus
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? |
---|---|---|---|---|
64716 | External lower-limb prosthesis suspensory component, powered |
A powered device intended to be integrated in the socket of an external lower limb prosthesis to provide prosthesis suspension by reducing the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It is designed as a vacuum pump (e.g., electric, mechanical) to provide increased vacuum inside the socket.
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Active | false |
64713 | External lower-limb prosthesis socket, non-customized |
A component of an external lower limb prosthesis designed to fit over a residual limb after amputation at any hip, knee, or ankle-foot level, and intended to function as the limb-prosthesis interface and to provide support, stabilization and suspension. This device is supplied as prefabricated components comprising the socket shell and typically suspension components (e.g., liner, sock, valve, lock, cuff, vacuum pump) ready to be assembled, fitted and adjusted to the patient.
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Active | false |
64712 | External lower-limb prosthesis socket, custom-made |
A component of an external lower limb prosthesis designed to fit over a residual limb after amputation at any hip, knee, or ankle-foot level, and intended to function as the limb-prosthesis interface and to provide support, stabilization and suspension. A customized socket (shell) is produced for a specific patient using a cast or 3-D anatomical imaging and is manufactured from various materials (e.g., carbon fibre, duroplast, thermoplast, wood, aluminium) either manually or using computer-based techniques. Prefabricated components which provide suspension and stabilization (e.g., liner, sock, valve, sleeve, vacuum pump) are often added to the socket shell to produce a finished socket.
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Active | false |
41536 | External limb prosthesis socket liner |
A flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ISP | Valve, Prosthesis |
IPM | Cover, Limb |
ISS | Prosthesis, Thigh Socket, External Component |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cf261ea1-6fb3-429d-a718-1a49e354346b
March 31, 2025
1
March 21, 2025
March 31, 2025
1
March 21, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
740-869-3377
xx@xx.xx
xx@xx.xx