Duns Number:007883297
Device Description: 23ga Tapered Flexible Curved Illuminated Laser Probe, Alcon/Coherent Laser Connector, Shor 23ga Tapered Flexible Curved Illuminated Laser Probe, Alcon/Coherent Laser Connector, Short 19ga Needle Illumination Connector, Box of 10
Catalog Number
-
Brand Name
23ga Tapered Flex Curved Illum Laser Probe, Alcon/Coherent Laser Connector
Version/Model Number
V6315-23BV
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
K121187,K121187
Product Code
HQB
Product Code Name
Photocoagulator And Accessories
Public Device Record Key
81899ad7-fc61-4512-b08a-765a32e9d3ef
Public Version Date
May 07, 2019
Public Version Number
4
DI Record Publish Date
March 24, 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 | 1640 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 288 |