DEVICE: One (00194711301386)

Device Identifier (DI) Information

One
ONE-TTVD-LG-XL
In Commercial Distribution
ONE-TTVD-LG-XL
Willowwood Global LLC
00194711301386
GS1

1
004280723 *Terms of Use
One TT System, LimbLogic Distal, Large Liner, Extra Large Sleeve
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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.
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.
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.
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).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ISP Valve, Prosthesis
IPM Cover, Limb
ISS Prosthesis, Thigh Socket, External Component
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8cf7dbc6-2510-4e68-9505-d00e9a22ecaf
March 31, 2025
1
March 21, 2025
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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)

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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
740-869-3377
xx@xx.xx
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