Duns Number:316957240
Device Description: HF-resection electrode, loop,
Catalog Number
A22259A
Brand Name
Olympus
Version/Model Number
A22259A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 16, 2018
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
-
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
GCP
Product Code Name
Endoscope, Ac-Powered And Accessories
Public Device Record Key
b715f3c8-83cf-45bd-b8b1-526cbc56d223
Public Version Date
August 04, 2022
Public Version Number
4
DI Record Publish Date
September 21, 2016
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 1109 |