Duns Number:962532441
Device Description: When added scope siffness is desired to negotiate a difficult colon, and prior to repositi When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual.These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes.
Catalog Number
ZUTR161700
Brand Name
Zutron Medical
Version/Model Number
ZUTR161700
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FDF
Product Code Name
Colonoscope And Accessories, Flexible/Rigid
Public Device Record Key
d5c10820-c01e-44ce-934d-83539e31c44c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 01, 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. | 4 |