Duns Number:690635461
Device Description: It is used to deliver the laser beam from the main laser device into the eye. The steriliz It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters.
Catalog Number
-
Brand Name
Sterilized Endophoto Probe(23G/Angled)
Version/Model Number
11143-6400
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
Yes
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
83010fee-af9c-4d72-9ab7-29c8e2dc30de
Public Version Date
May 24, 2018
Public Version Number
1
DI Record Publish Date
April 23, 2018
Package DI Number
04987669100356
Quantity per Package
5
Contains DI Package
04987669101261
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |