Robotics Oem

Basic Information

• Brand Name: Robotics Oem
• Primary DI: 04056481006105
• Version / Model: 49703
• Catalog Number: 49703
• Company Name: Brainlab AG
• Labeler DUNS: 314482980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: b8c072db-65b7-4082-93cd-7a2784e80d6f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAI	Couch, Radiation Therapy, Powered	Radiology	892.5770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04056481006105	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K120520	000