AccessGUDID - DEVICE: Exactrac Robotics (04056481006112)

GUDID

Device Identifier (DI) Information

Brand Name: Exactrac Robotics
Version or Model: 49702
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 49702
Company Name: Brainlab AG

Primary DI Number: 04056481006112
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 314482980 *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?
40683	Therapeutic x-ray system table, powered	A powered/programmable radiotherapy table specifically designed to position and support a patient during treatments administered using a therapeutic x-ray system. It has electronic and/or software controls for table top height and positioning. It can be a stationary or mobile unit, or incorporated as an integral component of a therapeutic x-ray system design.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAI	Couch, Radiation Therapy, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120520	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3e172455-68d4-43ea-92f7-60523a1c6ec1
Public Version Date: October 10, 2023
Public Version Number: 5
DI Record Publish Date: September 15, 2016