TECHNOLAS TENEO 317

Basic Information

• Brand Name: TECHNOLAS TENEO 317
• Primary DI: 04050555004202
• Version / Model: Model2
• Company Name: Technolas Perfect Vision GmbH
• Labeler DUNS: 341325716
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-17
• Public Version: 1
• Public Version Date: 2023-12-25
• Public Version Status: New
• Public Device Record Key: 90587687-49d8-4c02-b1aa-02b61d89c372

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
LZS	Excimer Laser System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
17702	Ophthalmic excimer laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power laser beam intended for corneal ablation (i.e., photorefractive keratectomy) and other ophthalmologic procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity). It includes a light source and controls/foot-switch, and is typically coupled to a biomicroscope slit lamp or to an indirect ophthalmoscope by a flexible fibreoptic cable. It does not include femtosecond pulsing or fundus imaging technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050555004202	GS1