Duns Number:622467348
Device Description: 25GA Curved Illuminating Laser Probe - Short
Catalog Number
-
Brand Name
25GA Curved Illuminating Laser Probe - Short
Version/Model Number
PD725.37SDD
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
-
Product Code
HQB
Product Code Name
Photocoagulator And Accessories
Public Device Record Key
583fbfc5-7a2e-4173-b37d-fd87ce01d795
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 13, 2017
Package DI Number
10632307002196
Quantity per Package
6
Contains DI Package
00632307002199
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 |