Duns Number:312889060
Device Description: Laser Surgery Fiber, core 320µm, clad 385µm, fiber OD 415µm, polyimide coating, standard S Laser Surgery Fiber, core 320µm, clad 385µm, fiber OD 415µm, polyimide coating, standard SMA 905 connector with knurl nut, PVC protection cap, extension sleeve red engraved, black bend protection, Silicone tubing OD 2mm, distal flat tip, cleaved, 10cm freestanding fiber, NA 0.22, length 3m +/-0,2m, sterile EO, disposable, single packed,
Catalog Number
-
Brand Name
NA
Version/Model Number
Dental Surgery Fiber 320µm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K140470
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
d8ab4c82-e413-4c16-8bf4-ae5945a81746
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
February 18, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |