AccessGUDID - DEVICE: Armboard 24" Cross Table (10841962109670)

GUDID

Device Identifier (DI) Information

Brand Name: Armboard 24" Cross Table
Version or Model: 8001217
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8001217
Company Name: Qfix

Primary DI Number: 10841962109670
Issuing Agency: GS1
Commercial Distribution End Date: April 19, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 808875397 *Terms of Use

Device Description: Armboard 24" Cross Table

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):	Yes
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?
40900	Radiological arm/leg positioner	A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDC	TABLE, OPERATING-ROOM, ELECTRICAL

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
Width: 24 Inch
Device Size Text, specify: Fits 24" table

Device Record Status

Public Device Record Key: 4f4a8be9-c0b5-4bf9-a83b-4fdbcdd8e144
Public Version Date: December 11, 2023
Public Version Number: 5
DI Record Publish Date: September 13, 2016