Duns Number:071595540
Device Description: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 20mm/60F, Multipack
Catalog Number
000867
Brand Name
ELIMINATOR
Version/Model Number
000867
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
K033936,K033936,K033936
Product Code
KNQ
Product Code Name
Dilator, esophageal
Public Device Record Key
0e25eeb6-8404-498c-b760-9d0ed8105214
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10653405052623
Quantity per Package
5
Contains DI Package
20653405052620
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |