AccessGUDID - DEVICE: AMG Medical Foam Invalid Ring (00775757451732)

GUDID

Device Identifier (DI) Information

Brand Name: AMG Medical Foam Invalid Ring
Version or Model: 745-173
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A.M.G. Médicale Inc

Primary DI Number: 00775757451732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207372814 *Terms of Use
Previous DI: 77575745173200

Device Description: Molded cushion with an open center that helps relieve pressure by distributing body weight evenly. Made of urethane foam fill with a removable, washable white cloth cover.

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?
41058	Multifunction body cushion	A soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIC	Cushion, Flotation

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: a8fb0af0-af6d-4997-b59c-e4c949e05a6f
Public Version Date: August 21, 2020
Public Version Number: 2
DI Record Publish Date: September 14, 2018