AccessGUDID - DEVICE: SLIDING BOARD,8X30,TWO CUTOUTS (00840314801647)

GUDID

Device Identifier (DI) Information

Brand Name: SLIDING BOARD,8X30,TWO CUTOUTS
Version or Model: 5086-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hausmann Enterprises, LLC

Primary DI Number: 00840314801647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001892660 *Terms of Use

Device Description: No description.

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?
35783	Wheelchair lap tray	A device designed as a flat or shallow board or vessel that is attached to a wheelchair and placed across the lap of the occupant to serve as a platform for the performance of routine activities (e.g., eating, working or carrying objects).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMX	Board, Lap, Wheelchair

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: fd1631b9-7aea-4ef5-b094-f7a50420f7ee
Public Version Date: August 24, 2022
Public Version Number: 1
DI Record Publish Date: August 16, 2022