Duns Number:690635461
Device Description: The scan attachable delivery unit is mainly comprised of a photocoagulation unit and a pro The scan attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. They are attached to the HAAG 900BQ slit lamp to comprise a scan slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator,Model MC-500 main body to comprise the photocoagulation system. A photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp.
Catalog Number
-
Brand Name
Scan attachable delivery unit (900BQ)
Version/Model Number
17468-0000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
86f5541c-06f7-46a5-8bf5-d71d88e45085
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |