AccessGUDID - DEVICE: NA (10810030863462)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM120-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM120-S
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030863462
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Wall Mount Rack for Patient Slider Boards. Constructed of stainless steel material for ease of cleaning and prevention of infection spread. Hook holds small or large size patient transfer slider boards. Keeps boards clean and out of the way, yet in the spot you need them. Each rack holds one board. Mounting hardware not included due to varying substrates.

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?
37164	Patient position turntable	A non-powered, manual device typically in the form of a rotating flat plate/disk intended to be positioned under a patient's buttocks or feet (when standing) to allow healthcare provider to pivot the patient for a change in position or direction, typically to facilitate proximal patient transfer (e.g., from bed to toilet); it has no lifting capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMR	Device, Transfer, Patient, Manual

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: 6 Inch
Height: 2 Inch
Depth: 2 Inch

Device Record Status

Public Device Record Key: 4db481c2-3e67-4200-ab35-bd38dcd6f918
Public Version Date: January 11, 2023
Public Version Number: 1
DI Record Publish Date: January 03, 2023