AccessGUDID - DEVICE: Medstone (07332339222246)

GUDID

Device Identifier (DI) Information

Brand Name: Medstone
Version or Model: Snap-on Arm Board with Pads
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 505-1111
Company Name: Stille AB

Primary DI Number: 07332339222246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355280827 *Terms of Use

Device Description: Snap-on Arm Board with Pads that attaches to the side rails. Accessory for Medstone Table, Examination, Medical, Powered

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?
40658	Fluoroscopy/angiography table, powered	A powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).	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
No Device Sizes

Device Record Status

Public Device Record Key: fbcdbe42-9a92-4352-b691-4fe93fe5eed4
Public Version Date: October 02, 2020
Public Version Number: 1
DI Record Publish Date: September 24, 2020