Duns Number:968623467
Device Description: Channel Steerable Sheath, 9 French
Catalog Number
M004CS200
Brand Name
Boston Scientific Channel Steerable Sheath
Version/Model Number
M004CS200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 25, 2019
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
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
246daf21-fc15-4fca-9d25-9d24a8451fb9
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
February 06, 2018
Package DI Number
10821329000666
Quantity per Package
1
Contains DI Package
00821329000669
Package Discontinue Date
July 25, 2019
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 275 |
| 3 | A medical device with high risk that requires premarket approval | 68 |