AccessGUDID - DEVICE: Scan attachable delivery unit (900BQ) (04987669100943)

GUDID

Device Identifier (DI) Information

Brand Name: Scan attachable delivery unit (900BQ)
Version or Model: 17457-0000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669100943
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a green laser beam (532 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system that ensures low laser power density on the anterior segment is incorporated. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). HAAG 900 BQ type is available.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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
HQF	Laser, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45a3b2cc-2ee1-4b82-931a-46ab030b88a7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 14, 2016