AccessGUDID - DEVICE: Weight Bearing DRP Holders (00860001700176)

GUDID

Device Identifier (DI) Information

Brand Name: Weight Bearing DRP Holders
Version or Model: WDDR[X]
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Reina Imaging

Primary DI Number: 00860001700176
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102370137 *Terms of Use

Device Description: Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor

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?
11772	Footstool	A platform, with or without legs, designed for a person to stand upon to compensate for differences in height or to place the feet/legs upon for rest/support when seated. It may be conductive to reduce the risk of static electricity when used in areas such as examination rooms or operating theatres, or non-conductive.	Active	false
64687	Flat panel x-ray detector/film cassette weight-bearing protector	A device intended to cover a flat panel x-ray detector or film cassette (neither included) on which a patient stands, to protect the cassette/detector from the patient’s body weight during a computed or digital radiography procedure of the feet. It is made of radiolucent materials with low x-ray attenuation/scattering. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZM	Stool, Operating-Room

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: 211b237b-3b75-4c61-ba7c-88716fb1b0c7
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023