Duns Number:771051935
Device Description: LAPAROSCOPIC INSTRUMENT SYSTEM5mm x 240mm scissor insertEndoscopic electrosurgical electro LAPAROSCOPIC INSTRUMENT SYSTEM5mm x 240mm scissor insertEndoscopic electrosurgical electrode, monopolar, single-use - 61875
Catalog Number
-
Brand Name
Logi
Version/Model Number
459-7000
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
Yes
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,K111986
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
0770682f-16e8-4b08-8973-c1021e7fad21
Public Version Date
March 30, 2020
Public Version Number
4
DI Record Publish Date
January 04, 2017
Package DI Number
05051986011905
Quantity per Package
10
Contains DI Package
05051986011899
Package Discontinue Date
December 31, 2019
Package Status
Not in Commercial Distribution
Package Type
Inner
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 335 |