Lunaris® Essential LESC3SXXZ

GUDID 05404036502838

Articulated prosthetic ankle-foot component with spring category C3. The device is intended for the replacement of the ankle and foot function as a component of a prosthesis that compensates for an absent or deficient lower limb.

Axiles Bionics

Mechanical-resistance external ankle-foot prosthesis
Primary Device ID05404036502838
NIH Device Record Keyfebff3c7-8df5-42a4-a331-87e1e7437618
Commercial Distribution StatusIn Commercial Distribution
Brand NameLunaris® Essential
Version Model NumberLunaris Essential
Catalog NumberLESC3SXXZ
Company DUNS371723288
Company NameAxiles Bionics
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9999999999
Emailinfo@axilesbionics.com
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Emailinfo@axilesbionics.com
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Phone9999999999
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Phone9999999999
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Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com
Phone9999999999
Emailinfo@axilesbionics.com

Device Dimensions

Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0
Length24 Centimeter
Length25 Centimeter
Length26 Centimeter
Length27 Centimeter
Length28 Centimeter
Length29 Centimeter
Length30 Centimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS105404036502838 [Primary]

FDA Product Code

ISHComponent, External, Limb, Ankle/Foot

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-20
Device Publish Date2025-05-12

On-Brand Devices [Lunaris® Essential]

05404036502876Articulated prosthetic ankle-foot component with spring category C7. The device is intended for
05404036502869Articulated prosthetic ankle-foot component with spring category C6. The device is intended for
05404036502852Articulated prosthetic ankle-foot component with spring category C5. The device is intended for
05404036502845Articulated prosthetic ankle-foot component with spring category C4. The device is intended for
05404036502838Articulated prosthetic ankle-foot component with spring category C3. The device is intended for
05404036502821Articulated prosthetic ankle-foot component with spring category C2. The device is intended for

Trademark Results [Lunaris]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LUNARIS
LUNARIS
86865006 5107958 Live/Registered
MuTracx International B.V.
2016-01-04
LUNARIS
LUNARIS
79334188 not registered Live/Pending
Axiles Bionics B.V.
2022-01-13
LUNARIS
LUNARIS
79188538 5215717 Live/Registered
AyoxxA Biosystems GmbH
2016-01-20
LUNARIS
LUNARIS
74395611 not registered Dead/Abandoned
Elecom Hanbai Kabushiki Kaisha
1993-05-25

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