Duns Number:265741780
Device Description: Single use, monopolar cautery scissors (curved blade) for laparoscopic surgery
Catalog Number
C5250
Brand Name
IN CUT scissors
Version/Model Number
C5250
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 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"
Yes
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
b5e1fe02-f986-4ff5-991f-8c03c23dae46
Public Version Date
October 18, 2019
Public Version Number
5
DI Record Publish Date
September 12, 2016
Package DI Number
03700393300493
Quantity per Package
5
Contains DI Package
03700393300363
Package Discontinue Date
April 30, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 839 |