Dornier MedTech

Basic Information

• Brand Name: Dornier MedTech
• Primary DI: 00810116020355
• Version / Model: 270 Micron Single Use
• Catalog Number: HOL270S
• Company Name: DORNIER MEDTECH AMERICA, INC.
• Labeler DUNS: 130789944
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-10
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 190571b5-55eb-45a8-b39a-fba457e24801

Device Description

Dornier SingleFlex 270 Laser Fiber - Dornier Direct

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36037	Laser lithotripsy system	An assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). The assembly transmits the laser energy to the stone(s) which fragment. The debris may be removed forcefully or passed out later by natural means.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810116020270	GS1	box	3	In Commercial Distribution
Primary	00810116020355	GS1

Premarket Submissions

Submission Number	Supplement Number
K121938	000