Duns Number:102422578
Device Description: Single-use optical fiber tip for use with the Precise SHP Diode Laser.
Catalog Number
-
Brand Name
Precise SHP 400um Fiber Tip
Version/Model Number
02824
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
K123443,K123443,K123443
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
a5df0e5d-a800-4d4f-9180-a99c7427bba2
Public Version Date
November 08, 2018
Public Version Number
4
DI Record Publish Date
November 10, 2016
Package DI Number
00872320001599
Quantity per Package
50
Contains DI Package
00872320003340
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| 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 |