Duns Number:763408366
Device Description: FCI directional LASER PROBE / EXTENDABLE 25G QUANTEL
Catalog Number
-
Brand Name
FCI directional LASER PROBE / EXTENDABLE 25G QUANTEL
Version/Model Number
S9.1323.25
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
HQB
Product Code Name
Photocoagulator And Accessories
Public Device Record Key
4d393dbc-4dd9-49c1-a16a-1ac321cc3ab5
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 30, 2021
Package DI Number
23700773723489
Quantity per Package
10
Contains DI Package
13700773723482
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 82 |
2 | A medical device with a moderate to high risk that requires special controls. | 291 |
U | Unclassified | 60 |