AccessGUDID - DEVICE: NA (10810030860461)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM612
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM612
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030860461
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: TKR Foot Rest (radiolucent). Assists in supporting legs for total knee replacement procedures. Constructed of stainless steel and polyoxy-methylene for ultimate support. Top portion is radiolucent. 5/8" diameter stainless steel post fits into Clark Socket (sold separately). Includes one single use disposable pad of soft black cushion. Replacement pads available for purchase separately. .

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?
55836	Leg procedure positioner	A non-powered, patient-contact, preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure), or during patient transfer to an operating table; it is not intended for application of traction forces. It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FWZ	Operating Room Accessories Table Tray

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: 12 Inch
Depth: 2 Inch
Height: 16.5 Inch

Device Record Status

Public Device Record Key: d4dab461-d222-46ae-bed9-acb74e47a951
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: September 01, 2020