AccessGUDID - DEVICE: NA (10810030860393)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM168
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM168
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030860393
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: The Insta-Rail quickly and easily attaches to your imaging table or other surface making it more versatile for your accessory needs. Features a clamp opening of 1 1/2". So it is designed to be compatible with all types of imaging tables. Stainless steel rail is 6" long x 1 1/8" high x 3/8" thick. It is the same type of rail used on all US made O.R. tables. .

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?
37050	Medical table clamp	A device that is designed to be used together with operating tables and certain kinds of examination/treatment tables. It can have different fixation/locking mechanisms, but is often designed to fit onto the side rails of such tables. It is used to hold different components and accessories onto the table providing added functionality. Such devices can be footrests, transducer holders, anaesthesia screen holders. The clamp allows for easy and safe adjustments of the position of these accessory devices and provides a secure locking mechanism. 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
Length: 6 Inch
Width: 3.5 Inch
Height: 3.75 Inch

Device Record Status

Public Device Record Key: 8af633d3-cf6f-4fbc-98de-edee0ca3ce4b
Public Version Date: September 09, 2020
Public Version Number: 1
DI Record Publish Date: September 01, 2020