Duns Number:690275362
Device Description: Articulated arm
Catalog Number
-
Brand Name
Edge ONE Arm
Version/Model Number
Edge ONE Arm
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162169
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
25268b7e-9b06-437f-a813-e84bef7324ed
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
November 18, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |