AccessGUDID - DEVICE: NA (10810030861611)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM501
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM501
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030861611
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: SS Instrument Table with Shelf. Our most common instrument table with lower shelf. Also known as a back table in the OR. Fully welded stainless steel construction. Shelf and top are constructed of 16 gauge stainless steel. Square legs offer more welding surface and more material for added strength and longevity. These tables are manufactured to our OR specifications and do not have any open cavities to collect unwanted substances. Non marking neoprene 3 inch casters come standard to make it easy to maneuver and protect the floors in your facility. All edges are glove friendly. Ships fully assembled.

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?
62638	Upper-limb traction wrap/trap, single-use	A preformed device designed to encompass the fingers, hand or forearm to create a holder which can be attached to an external frame to provide traction/suspension of the upper limb during surgical procedures on the hand, arm or shoulder. It is typically made of synthetic polymer textile (e.g., nylon) and includes self-retaining fasteners (e.g., Velcro); it may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQZ	Component, Traction, Non-Invasive

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: 16 Inch
Height: 34 Inch
Length: 20 Inch

Device Record Status

Public Device Record Key: 50446d65-ab6d-4c0b-bb24-d6cb20b2fd0d
Public Version Date: February 20, 2023
Public Version Number: 2
DI Record Publish Date: September 30, 2020