AccessGUDID - DEVICE: OrthoGold100® (04260484571601)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoGold100®
Version or Model: OW100-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1000013
Company Name: MTS Medical AG

Primary DI Number: 04260484571601
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342585299 *Terms of Use

Device Description: Indications for Use The OrthoGold100® is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blood circulation • Activation of connective tissue

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?
35538	Freestanding electric massager	An electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 82 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 82 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Weight: 18 Kilogram
Depth: 459 Millimeter
Width: 400 Millimeter
Height: 218 Millimeter

Device Record Status

Public Device Record Key: b0fd3628-c2a6-4874-8ad3-6e035459b137
Public Version Date: August 23, 2024
Public Version Number: 6
DI Record Publish Date: January 23, 2019