AccessGUDID - DEVICE: GALAXY (05903684801367)

GUDID

Device Identifier (DI) Information

Brand Name: GALAXY
Version or Model: TRACTION T4.F4 XL [SZER 70]
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3267
Company Name: MEDEN INMED SP Z O O

Primary DI Number: 05903684801367
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 367142903 *Terms of Use

Device Description: GALAXY Traction table TTET300, TTET400 is designed to support a patient and the therapist in traction treatment. The table surface may consist of sections that can be raised and lowered to manipulate the curvature of the patient’s spine and traction accessories for lumbar and cervical traction.

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?
46761	Body arch traction table	A fixed framework table designed to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch. The patient locks their feet behind a cross-member and bends backward over the curvature of the table to flex the vertebrae of the spine, relieving spinal compression, relaxing the shoulders, neck, and back muscles, whilst stretching and strengthening the core muscles of the body. This device can be used in a healthcare facility or in the home to assist patients eliminate/alleviate back pain.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INQ	Table, 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
Width: 70 Centimeter
Length: 202 Centimeter
Height: 98 Centimeter

Device Record Status

Public Device Record Key: ca6a717a-1303-4c77-a30c-dbc1bafca692
Public Version Date: November 11, 2022
Public Version Number: 1
DI Record Publish Date: November 03, 2022