AccessGUDID - DEVICE: Adante Traction Mount, Right (00842430117039)

GUDID

Device Identifier (DI) Information

Brand Name: Adante Traction Mount, Right
Version or Model: 6895-1148
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6895-1148
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430117039
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084527241 *Terms of Use

Device Description: No description.

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?
67461	Operating table/boot traction interface controller	An electrically-powered, orthopaedic device intended to be connected to an operating table orthopaedic extension at one end and hold a traction boot at the other end to: 1) electrically control the fine traction and enable locking/unlocking of the gross traction of the extension, and 2) manually rotate the patient’s foot, as part of a lower limb surgical procedure; the extension and boot are not included. It is an electrical unit with appropriate control handle/buttons, connectors, and a clamp-like device intended to hold the boot.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered

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: 4f8ef7bf-0325-41e9-9bcc-a6ba06fd59c7
Public Version Date: July 14, 2025
Public Version Number: 1
DI Record Publish Date: July 04, 2025