AccessGUDID - DEVICE: NA (10810030861444)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM410
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM410
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030861444
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Standard Drop-Latch Armboard. This armboard is designed to support patient’s arms during surgery. Standard droplatch style armboard for ease of use. Rotates 180 degrees to desired position with lever lock. Simply pull lever on underside at the outer end to adjust the rotation of the armboard. Clamps to any American made OR table rail with drop style lock. Simply lift the lever, fit the top of the clamp over the top of the table rail and release the lever to lock in place. .

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?
42308	Operating table orthopaedic extension, non-powered	A non-powered, orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates (e.g., leg spar).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NOD	Board, Arm (With Cover), Non-Sterile

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: 6 Inch
Length: 24 Inch
Height: 0.375 Inch

Device Record Status

Public Device Record Key: 64a31314-ac35-49b3-9769-9ef04b92cbdb
Public Version Date: February 06, 2025
Public Version Number: 4
DI Record Publish Date: September 30, 2020