AccessGUDID - DEVICE: GALAXY (05903684800896)

GUDID

Device Identifier (DI) Information

Brand Name: GALAXY
Version or Model: MERCURY E-S2.F0-H [SZER. 64]
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3120
Company Name: MEDEN INMED SP Z O O

Primary DI Number: 05903684800896
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 367142903 *Terms of Use

Device Description: The Galaxy massage table is a treatment table designed to facilitate manual therapies and massage treatments.

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?
42486	Examination/treatment table, hydraulic	A mobile table powered by manually-operated hydraulic mechanisms designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some hinged sections that can be adjusted into a raised position. The height of the table top surface will also be hydraulically-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.	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: 64 Centimeter
Length: 205 Centimeter
Height: 96 Centimeter

Device Record Status

Public Device Record Key: f56ec520-b42e-48a9-b94c-4d25f3360950
Public Version Date: November 11, 2022
Public Version Number: 1
DI Record Publish Date: November 03, 2022