AccessGUDID - DEVICE: McConnell Orthopedic MFG. CO. (00860013953515)

GUDID

Device Identifier (DI) Information

Brand Name: McConnell Orthopedic MFG. CO.
Version or Model: 15-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15-100
Company Name: MCCONNELL ORTHOPEDIC MFG. CO.

Primary DI Number: 00860013953515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 174128843 *Terms of Use

Device Description: Buttress Support Plate (Standard)

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):	Yes
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?
62650	Operating table torso positioner	A preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge, multi-jointed metal structure) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., shoulders, chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone, lateral, or Trendelenburg position; it may be adhesive or components for attachment to the operating table (e.g., adaptors, straps) may be included with the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWN	Table And Attachments, Operating-Room

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
No Device Sizes

Device Record Status

Public Device Record Key: a85e5c85-6171-4e46-9ff5-829367e418b4
Public Version Date: May 12, 2025
Public Version Number: 1
DI Record Publish Date: May 02, 2025