AccessGUDID - DEVICE: NA (10810030862908)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM530
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030862908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: SS Height Adjustable Instrument/Straddle Table, 28 inch Leg Clearance. Designed to straddle the OR Table during surgery to keep instruments and equipment directly adjacent to the surgical site. Heavy Duty 16 gauge #304 stainless steel construction. No mixed materials even on the underside of the table to ensure there is no corroding or rusting. Comes with 4 inch casters, 2 swivel, 2 locking. Adjusts in height with stainless steel handle and can be controlled from either end. Handle removes and stores on hook on the inner side of the leg. No open cavities to collect unwanted substances. Height adjusts from 36 inches-56inches. . .

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?
38664	Operating table accessory trolley	A cart typically designed as a framework on wheels with baskets, shelves, hooks and organizers that is used to store the operating table accessories in an orderly and hygienic manner. This trolley (cart) may be brought into the operation room (OR) so that a choice of operating table accessories, or accessories for a specific surgical procedure is made readily available.	Obsolete	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: 20 Inch
Length: 36 Inch
Height: 28 Inch

Device Record Status

Public Device Record Key: 19b18506-048f-4586-8962-b8c13181b3e5
Public Version Date: December 23, 2020
Public Version Number: 1
DI Record Publish Date: December 15, 2020