AccessGUDID - DEVICE: Split Leg Positioner Pair with Pad (00810105030303)

GUDID

Device Identifier (DI) Information

Brand Name: Split Leg Positioner Pair with Pad
Version or Model: 1-1013-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COMPOSITE MANUFACTURING, INC.

Primary DI Number: 00810105030303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947090650 *Terms of Use

Device Description: Carbon fiber split leg positioner device which allows for mid-line access to the patient with controls to independently adjust the legs for full abduction/adduction as well as positioning to high lithotomy. Ideal for Laparoscopic and orthopaedic procedures.

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?
55836	Leg procedure positioner	A non-powered, patient-contact, preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure), or during patient transfer to an operating table; it is not intended for application of traction forces. It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. 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: 87b0f38a-80f0-4f03-af5b-f41b3b7e97ff
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: February 14, 2020