AccessGUDID - DEVICE: NA (10810030860416)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM405
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM405
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030860416
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Made to add 4" to the width of your OR Table for wider patients or for certain procedures that may need a wider table. Quickly attaches to the OR Table side rail of any US made O.R. Table. Has a rail on the outer side for accessories so you don't loose any capability in the function of your O.R. Table. .

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?
37255	Universal operating table top	A component of a modular operating table designed as a detachable table top that can be adjusted to support a patient during many types of surgical interventions. It may consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or intended to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.	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: 4 Inch
Depth: 0.375 Inch
Length: 20 Inch

Device Record Status

Public Device Record Key: 6bb152fb-6f2e-45c6-a7a2-62b9292594b4
Public Version Date: September 09, 2020
Public Version Number: 1
DI Record Publish Date: September 01, 2020