Duns Number:152165700
Device Description: A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Catalog Number
-
Brand Name
Diode Laser Tips
Version/Model Number
EpiTip 4-9 Perio
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2016
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
3a83a754-8153-4e97-b7b9-935da02df774
Public Version Date
July 29, 2020
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
00647529001936
Quantity per Package
30
Contains DI Package
00647529000458
Package Discontinue Date
November 30, 2016
Package Status
Not 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 |