AccessGUDID - DEVICE: Oakworks Medical (00817463022513)

GUDID

Device Identifier (DI) Information

Brand Name: Oakworks Medical
Version or Model: Carbon Fiber Arm Board
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OAKWORKS, INC.

Primary DI Number: 00817463022513
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 130256837 *Terms of Use

Device Description: Carbon Fiber Arm Board with 4" pad

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):	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?
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
MMZ	Table, Cystometric, Electric
IZZ	Table, Radiographic, Non-Tilting, Powered
IXQ	Table, Radiographic, Stationary Top

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: 27a7ddc9-3cba-4ef0-8ee1-b74a1410e7f3
Public Version Date: January 01, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016