DEVICE: Attachable delivery unit (900BQ) (04987669100257)
Device Identifier (DI) Information
Attachable delivery unit (900BQ)
17172-0000
In Commercial Distribution
NIDEK CO.,LTD.
17172-0000
In Commercial Distribution
NIDEK CO.,LTD.
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.
• HAAG STREIT ................. Model 900BM, 900CN and 900BQ
• NIDEK ............................... Model SL-250 and SL-450
This model includes manipulator.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEX | Powered Laser Surgical Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9161254c-b7fe-41bd-af84-dd50edf38a2e
March 29, 2018
2
February 01, 2017
March 29, 2018
2
February 01, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-223-9044
info@nidek.com
info@nidek.com