AccessGUDID - DEVICE: Arion Easy-Off (08717127935192)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 08717127935192
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: Application aid (donning and doffing) for medical compression garments

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?
66053	Compression/pressure sock/stocking applicator	A flexible plastic device intended to be used to assist in the application of a compression/pressure sock/stocking, or arm sleeve, onto a patient’s limb. The sock/stocking is typically rolled over the limb-applied device which is pulled to advance the sock/stocking over the limb. This is a reusable device.	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: 21c26d67-4180-4068-a67d-f9d8c7426f56
Public Version Date: January 14, 2025
Public Version Number: 2
DI Record Publish Date: November 03, 2023