AccessGUDID - DEVICE: Goralign PSA 2 (00198168267684)

GUDID

Device Identifier (DI) Information

Brand Name: Goralign PSA 2
Version or Model: GPSA-2QY
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Impulse Technology, LLC.

Primary DI Number: 00198168267684
Issuing Agency: GS1
Commercial Distribution End Date: August 14, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 078834474 *Terms of Use

Device Description: Goralign PSA 2, where “PSA” stands for “Plus Shock Absorber”, is the next generation of Impulse Technology's prosthetic ankle that self-adapts to uneven terrain and enhances patient comfort and motion through its nonlinear stiffness featuring self-adaptation throughout all phases of gait. The self-adaptive feature helps mitigate gait changes due to terrain and misalignment over time by self- aligning.

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
No Device Sizes

Device Record Status

Public Device Record Key: 19378ac2-95ec-4298-9bc3-faf72d7ae863
Public Version Date: August 15, 2024
Public Version Number: 2
DI Record Publish Date: June 24, 2024