Attachable delivery unit (900BQ)

Basic Information

• Brand Name: Attachable delivery unit (900BQ)
• Primary DI: 04987669100264
• Version / Model: 17108-0000
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-03
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f75ff7e5-9987-42af-8091-9a34045b9c07

Device Description

This delivery unit is mounted on your HAAG type slit lamp and connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system. Moving the delivery unit aside allows the operator to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the slit lamp without removing the delivery unit. This unit is attachable to the following five slit lamps.*1 • HAAG STREIT ................. Model 900BM, 900CN and 900BQ • NIDEK ............................... Model SL-250 and SL-450 This model does not include manipulator.

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: 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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36150	General/multiple surgical frequency-doubled solid-state laser system	A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669100264	GS1

Customer Contacts

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