Duns Number:711789789
Catalog Number
-
Brand Name
ELECTROSURGICAL SNARE
Version/Model Number
SD-8P-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 15, 2022
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"
Yes
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
FAS
Product Code Name
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Public Device Record Key
fffe84da-7dbf-4a57-bd2d-676ee7e0a6a7
Public Version Date
August 16, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
14953170036030
Quantity per Package
1
Contains DI Package
04953170036033
Package Discontinue Date
August 15, 2022
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |