Duns Number:622467348
Device Description: 23GA Illuminating Laser Probe - Alcon
Catalog Number
-
Brand Name
23GA Illuminating Laser Probe - Alcon
Version/Model Number
PD723.30
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"
Yes
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
K031023,K031023
Product Code
HQF
Product Code Name
Laser, ophthalmic
Public Device Record Key
f45ad472-e803-45d2-85e5-f77ab5888ae5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 06, 2016
Package DI Number
10632307000420
Quantity per Package
5
Contains DI Package
00632307000423
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 | 30 |
2 | A medical device with a moderate to high risk that requires special controls. | 177 |