Duns Number:043618763
Catalog Number
-
Brand Name
Acculite EndoOto
Version/Model Number
24ga 15° Angled, SMA 905, 200µm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 21, 2020
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
-
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
47200a7b-3af6-44eb-81c8-9687dfe2f1f5
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
17290109140855
Quantity per Package
10
Contains DI Package
07290109140858
Package Discontinue Date
February 21, 2020
Package Status
Not 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. | 48 |