Duns Number:071595540
Device Description: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 12mm/36F, Multipack
Catalog Number
000857
Brand Name
ELIMINATOR
Version/Model Number
000857
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2022
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
K940965,K940965,K940965
Product Code
KGE
Product Code Name
FORCEPS, BIOPSY, ELECTRIC
Public Device Record Key
c26b3dd8-fb55-4d6c-ab1d-843d5bfd6780
Public Version Date
June 06, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10653405052593
Quantity per Package
5
Contains DI Package
20653405052590
Package Discontinue Date
June 04, 2022
Package Status
Not 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 |