AccessGUDID - DEVICE: NA (10810030861215)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM321
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM321
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030861215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Hourglass Phenolic Arm and Hand Surgery Table W/Double Leg and 2" Pad. his hourglass shaped arm/hand table is constructed of durable phenolic like the surface of the OR table. The hourglass shape extends to 24" width to provide wrist support for the surgeon. It clamps securely to the OR table rail and has a drop down leg for added support. Radiolucent center portion allows c-arm access. Clamps securely to the OR table rail with our integral posi-lock clamps. No extra clamps needed or to get misplaced. 15" x 32" operating surface and plenty of lower support. Leg adjusts up to 12" to meet the ideal height for the surgeon. Double lower foot option adds stability to the leg end of the table. 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: 32 Inch
Width: 24 Inch
Height: 5.5 Inch

Device Record Status

Public Device Record Key: 13e5ab70-a5ea-4b8c-bfdf-0e3b2ed3ee9c
Public Version Date: February 06, 2025
Public Version Number: 4
DI Record Publish Date: September 15, 2020