AccessGUDID - DEVICE: NA (10810030861185)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM320-MB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM320-MB
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030861185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Hourglass shaped arm and hand table with mobile base and locking casters. Arm hand tables with Mobile bases offer the best of versatility. Able to roll from room to room without the nurses having to lift them is a great benefit. Adjusts in height from 30"-42". They come equipped with four locking casters. Hourglass shape is popular because it allows a wide 24" outer edge for wrist support of the surgeon during surgery. 15" x 32" operating surface with excellent c-arm capabilities make this table a great fit where an hourglass shape is preferred. This option simply rolls up to the OR table or stretcher and is held in place by the locking casters. Works for performing surgery on OR table, stretcher and/or stretcher chair. 2" pad 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?
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
HRK	Table, Instrument, Manual, Ophthalmic

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: 34 Inch
Width: 24 Inch
Height: 31 Inch

Device Record Status

Public Device Record Key: 19fe5aea-a500-4a20-bb34-71c1ee6b413c
Public Version Date: February 06, 2025
Public Version Number: 4
DI Record Publish Date: September 15, 2020