Duns Number:102422578
Device Description: Fiber cleaving tool for use with the Precise LTM Diode Laser.
Catalog Number
002-00204
Brand Name
Precise LTM Fiber Cleaver
Version/Model Number
002-00204
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062619
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
d03652c9-e5ca-4a7c-ab13-e55bb3d0a905
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 10, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |