Duns Number:554536935
Device Description: Disposable OTW Esophageal Dilators
Catalog Number
-
Brand Name
CONMED CleanGuide
Version/Model Number
CG-05-1
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"
-
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
KNQ
Product Code Name
Dilator, Esophageal
Public Device Record Key
ca5658ae-2911-435c-ac25-96f50f13a882
Public Version Date
August 27, 2021
Public Version Number
2
DI Record Publish Date
April 11, 2021
Package DI Number
16971890564532
Quantity per Package
3
Contains DI Package
06971890564535
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box