Duns Number:314885641
Device Description: Otology probe curved tip 20° universal centering
Catalog Number
LL28059s
Brand Name
Laser Surgery Fibers and Probes
Version/Model Number
LL28059s
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
K161403,K161403,K161403,K161403
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
cbac6d66-2e8a-45c8-8682-5c8f737ff534
Public Version Date
April 07, 2021
Public Version Number
6
DI Record Publish Date
October 28, 2016
Package DI Number
04260155591921
Quantity per Package
30
Contains DI Package
04260155591518
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |