Duns Number:690635461
Device Description: The Attachable Delivery Unit (for ZEISS SL130) (hereafter called “attachable delivery unit The Attachable Delivery Unit (for ZEISS SL130) (hereafter called “attachable delivery unit”) is attached to the Carl Zeiss Meditec SL130 (hereafter called Zeiss SL130) to comprise a slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the GYC-1000 to comprise aphotocoagulation system. The attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit.
Catalog Number
-
Brand Name
Attachable delivery unit (SL130)
Version/Model Number
17404-0000
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
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
ea22012a-fce2-47be-a374-2b94b7c7a45a
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 |