Duns Number:690635461
Device Description: This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-50 This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body, to comprise the photocoagulation system and to treat affected areas using the slit lamp, Carl Zeiss Meditec 30 SL/M. This delivery unit is mainly comprised of the delivery unit, protective filter unit, and the split illumination mirror unit. This 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. This delivery unit can be attached only to the Carl Zeiss Meditec 30 SL/M.
Catalog Number
-
Brand Name
Attachable delivery unit (30SL)
Version/Model Number
17461-0000
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
a1ea6c79-b796-4c96-a190-4d2a0a4c6f26
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 |