AccessGUDID - DEVICE: NA (10810030860249)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM107
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM107
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030860249
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Anesthesia Protection Shield. This stainless steel anesthesia shield is designed to protect the patient’s face during surgery and also provides a frame for the anesthesia drape. Constructed of durable stainless steel, it attaches to the OR table rail with two stainless steel side rail sockets (MCM-162 sold separately). Top surface measures 18 1/4" by 22 1/4" and the side supports are 24"L to adjust to the desired height. Side supports measure 1/8" x 1". The flat tray portion can be used to support instruments during surgery. Allows full patient access for anesthesia monitoring. Fully welded stainless steel construction makes it easy to clean and durable.

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?
35501	Anaesthesia screen	A frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device.	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: 22.25 Inch
Depth: 18.25 Inch
Height: 24 Inch

Device Record Status

Public Device Record Key: 16dd784e-2d93-4ef7-9e6b-421924a9520e
Public Version Date: September 09, 2020
Public Version Number: 1
DI Record Publish Date: September 01, 2020