AccessGUDID - DEVICE: NA (10810030860195)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM142
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM142
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030860195
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Non-skid L-Shaped Rubber Foot for Stacking Interlocking Surgical Step Stool. Fits Mid Central Medical stools, may or may not fit other manufacturers stools. Easily glued on with silicone or Super Glue, not included.

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?
42809	Assistive stool/step	A platform designed or adapted for a disabled person to stand upon to compensate for differences in height, to place the feet/legs upon for rest/support when seated, and/or to sit upon. It may include legs, hand rails, and/or suction cups to attach to a surface, and may be used inside, outside or in a bath. It may be used to facilitate comfort, to correct lower-limb positioning during a treatment, or to compensate for an injury, temporary or permanent disability. This is a reusable device.	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
Length: 2 Inch
Depth: 2 Inch
Height: 1.25 Inch

Device Record Status

Public Device Record Key: 4521f224-b482-4d8e-8669-3b2db07a79a7
Public Version Date: January 22, 2021
Public Version Number: 3
DI Record Publish Date: September 01, 2020