Duns Number:801895244
Device Description: Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French
Catalog Number
-
Brand Name
CooperSurgical, Inc.
Version/Model Number
47-9005
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
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
GBA
Product Code Name
Catheter, Balloon Type
Public Device Record Key
65075d98-7480-4c50-b467-3a09b152d119
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2016
Package DI Number
30888937003247
Quantity per Package
20
Contains DI Package
60888937003248
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |