AccessGUDID - DEVICE: NA (10810030861369)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM345
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM345
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030861369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: 24 inch L Horizontal Traction Tower for Hourglass Tables. Solid Stainless Steel Construction. Adapts easily to most arm and hand tables. For Mid Central Medical Tables, It simply attaches to blue clamp that hold the leg. .75 inches outside square tube with .5 inches telescoping tube provides the strongest and most dependable device available. Knob tightens at any position. Comes with cable and connections for traction devices.

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?
46511	Surgical traction tensioner	A hand-operated tensioning device designed to be attached to a patient-contact device (e.g., hand wrap/trap, pelvic bone pin, foot boot, skull tongs) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis), typically during orthopaedic procedures (e.g., cervical spine surgery, pelvic reconstruction, fracture reduction). It may be a floor-standing pole or attached to an operating table or table extension, and typically consists of a multi-jointed structure with metal bars/posts, a manual screw/crank for traction adjustment, and mounting clamps/adaptors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOX	Stand, Infusion

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
Height: 9.5 Inch
Length: 9 Inch

Device Record Status

Public Device Record Key: 680154f3-2594-4b42-8dce-0b202fa6c295
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020