AccessGUDID - DEVICE: Lunaris® Essential (05404036502869)

GUDID

Device Identifier (DI) Information

Brand Name: Lunaris® Essential
Version or Model: Lunaris Essential
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LESC6SXXZ
Company Name: Axiles Bionics

Primary DI Number: 05404036502869
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 371723288 *Terms of Use

Device Description: Articulated prosthetic ankle-foot component with spring category C6. 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64723	Mechanical-resistance external ankle-foot prosthesis	A mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media). The device may have various designs and functional features (e.g., SACH, SAFE, partial-foot, energy-storing carbon fibre spring blade type, adjustable heel height, split/sandal toe) for support during a variety of activities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISH	Component, External, Limb, Ankle/Foot

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Centimeter
Length: 25 Centimeter
Length: 26 Centimeter
Length: 27 Centimeter
Length: 28 Centimeter
Length: 29 Centimeter
Length: 30 Centimeter
Device Size Text, specify: Side, Left (L) / Right (R)

Device Record Status

Public Device Record Key: 1a4ad404-49a3-4743-a15c-0011c2d1a8d4
Public Version Date: May 20, 2025
Public Version Number: 1
DI Record Publish Date: May 12, 2025