AccessGUDID - DEVICE: NA (10810030861703)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM508
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM508
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030861703
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 and include braces for added rigidity and to help alleviated vibration in transit. 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 three 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?
13959	Instrument table	A table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table.	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
Width: 24 Inch
Length: 60 Inch
Height: 34 Inch

Device Record Status

Public Device Record Key: 82d9105b-dde3-4df8-9c72-49f79559b6d6
Public Version Date: November 09, 2020
Public Version Number: 1
DI Record Publish Date: October 31, 2020