Duns Number:800214827
Device Description: 6 French esophageal octapolar recording catheter, (single unit package).
Catalog Number
1600
Brand Name
Tapcath
Version/Model Number
1600, single pack
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
K905831,K905831
Product Code
DRF
Product Code Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Public Device Record Key
bce3bb23-eb45-405e-b766-312b01bf5a70
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 22, 2015
Package DI Number
10856233005056
Quantity per Package
5
Contains DI Package
00856233005059
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box of 5 units
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 17 |