Duns Number:020198912
Device Description: Endocut Scissor Tip
Catalog Number
3142-MICROLINE
Brand Name
N/A
Version/Model Number
N/A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NUJ
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
Public Device Record Key
b052c1f3-a3f6-4f23-9924-6be282f858fb
Public Version Date
February 21, 2022
Public Version Number
6
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 304 |
2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
U | Unclassified | 12 |