Duns Number:690635461
Device Description: The attachable delivery unit is attached to the Carl Zeiss 30SL/M (hereafter called Zeiss The attachable delivery unit is attached to the Carl Zeiss 30SL/M (hereafter called Zeiss 30SL/M) to comprise a slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the MC-500 to comprise a photocoagulation system. The 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. The attachable delivery unit is mainly comprised of a photocoagulation unit, a protective filter unit, and a split mirror illumination unit.
Catalog Number
-
Brand Name
Scan attachable delivery unit (30SL/M)
Version/Model Number
17465-0000
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
9481b91e-f2a7-4156-8ea6-4160ea7d8c42
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 24, 2016
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 |