Duns Number:771051935
Device Description: LAPAROSCOPIC INSTRUMENT SYSTEMPistol Grip non ratchetElectrocautery System Handpiece
Catalog Number
-
Brand Name
Logic
Version/Model Number
459-43000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111986
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
bf9bafc2-3d0b-4a3b-8a16-92777e9f0d40
Public Version Date
March 30, 2020
Public Version Number
4
DI Record Publish Date
September 23, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 335 |