Duns Number:622467348
Device Description: 20GA Hard Tip Aspirating Laser Probe - Alcon
Catalog Number
-
Brand Name
20GA Hard Tip Aspirating Laser Probe - Alcon
Version/Model Number
PD720.60HT
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
K061024,K061024
Product Code
HQE
Product Code Name
INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
Public Device Record Key
1823e5e3-0920-45ca-8fd0-5076e0ce7ed6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 06, 2016
Package DI Number
10632307000284
Quantity per Package
5
Contains DI Package
00632307000287
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 |