AccessGUDID - DEVICE: NA (10810030863110)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM770
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM770
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030863110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: SS Ventric Stand. For those situations where you need a huge mayo stand. Top tray does not remove like a mayo stand. Weight capacity is 100 lbs. evenly distributed. Rail around top keeps instruments from rolling off table top. Great for use in ortho cases. Comes standard with 4” casters, 2 braking. Handle removes and stores inside leg. Height adjusts from 36-56”. Weight capacity is 100 lbs. evenly distributed. Rail around top keeps instruments from rolling off table top. Great for use in ortho cases. ‘T’ base measures 28” x 30” .

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
FWZ	Operating Room Accessories Table Tray

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: 26 Inch
Length: 30 Inch
Height: 56 Inch

Device Record Status

Public Device Record Key: 0c769a7d-f94d-416d-8658-fb9425d01c30
Public Version Date: January 08, 2021
Public Version Number: 1
DI Record Publish Date: December 31, 2020