Duns Number:090101258
Device Description: The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 235 cm.
Catalog Number
ES26235
Brand Name
ENSIZOR
Version/Model Number
ES26235
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
OCZ
Product Code Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Public Device Record Key
58b82e82-8ca4-41c1-bf47-3e806ba238a4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 23, 2016
Package DI Number
M707ES262351
Quantity per Package
3
Contains DI Package
M707ES26235
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box