AccessGUDID - DEVICE: NA (10810030863141)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM851
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM851
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030863141
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Surgical Stool with Brushed Aluminum Base. Surgical stools are a very important feature in any OR. This seating has many different colors of 15.75 inch diameter vinyl tops. Rotation lock on seat keeps stable when needed. Designed specifically for the OR with waterfall seams for easy cleaning and foot control height adjustment. Adjusts from 19.5 inch – 26.5 inch. Weight capacity 300 lbs. .

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?
32307	Operating room stool	A seat, usually padded and height-adjustable, intended to be occupied by operating room (OR) staff during surgical procedures as an alternative to standing; it does not include support for the back or arms. It is intended to be used in ORs or cleanrooms and is therefore constructed so that it is easy to clean to help minimize risk of contamination.	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
Width: 24 Inch
Length: 24 Inch
Height: 19.5 Inch

Device Record Status

Public Device Record Key: b1f64845-0dda-4d0d-ae62-329a11fac4f6
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: December 15, 2020