Dornier MedTech

Basic Information

• Brand Name: Dornier MedTech
• Primary DI: 04049957000714
• Version / Model: Relax+
• Catalog Number: K1018869
• Company Name: Dornier MedTech GmbH
• Labeler DUNS: 388104085
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-13
• Public Version: 2
• Public Version Date: 2024-02-06
• Public Version Status: Update
• Public Device Record Key: 039eed76-3f0a-45f9-886c-d9fcdbb03b25

Device Description

Relax+ Mobile Examination Table

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
KQS	Table, Cystometric, Non-Electric And Accessories	Gastroenterology, Urology	876.4890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40680	Multi-purpose diagnostic imaging table	An electrically-powered multi-purpose device intended to support and position a patient in conjunction with multiple diagnostic imaging procedures (e.g., x-ray, nuclear medicine or ultrasound). It may contain a variable number of articulated joints to facilitate patient positioning and incorporates electronic or software controls for table height, motion, and/or table top position.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049957000714	GS1

Premarket Submissions

Submission Number	Supplement Number
P840008	069