Duns Number:152165700
Device Description: A single-use fiberoptic pre-initiated tip intended for use with diode laser systems.
Catalog Number
7400071
Brand Name
Diode Laser Tips
Version/Model Number
Pre-initiated, Surgical, 3-4
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
K121286,K121286
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
cbee8949-9bee-4e90-99b5-8ea7970f32a2
Public Version Date
July 29, 2020
Public Version Number
5
DI Record Publish Date
November 30, 2016
Package DI Number
00647529003404
Quantity per Package
30
Contains DI Package
00647529003343
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 155 |