Duns Number:774856749
Catalog Number
-
Brand Name
Laser Applicator Non-cooled
Version/Model Number
4012-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K151569,K201466,K151569,K201466,K151569,K201466
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
a82aeb7c-5ba7-4d3a-b772-aa7e86b8464d
Public Version Date
October 10, 2022
Public Version Number
7
DI Record Publish Date
September 18, 2016
Package DI Number
57340007000176
Quantity per Package
10
Contains DI Package
17340007000178
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |