AccessGUDID - DEVICE: Arion Proth-Pro (08717127936670)

GUDID

Device Identifier (DI) Information

Brand Name: Arion Proth-Pro
Version or Model: Large
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Arion Holding B.V.

Primary DI Number: 08717127936670
Issuing Agency: GS1
Commercial Distribution End Date: January 13, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 489495862 *Terms of Use

Device Description: Donning aid for transfemoral prostheses

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
Over the Counter (OTC):	Yes
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?
31050	Assistive sock/pantyhose dressing device	A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPM	Cover, Limb

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: ba3751c6-d137-4617-945c-0b3d75ae8840
Public Version Date: January 14, 2025
Public Version Number: 2
DI Record Publish Date: November 03, 2023