Duns Number:208993667
Device Description: The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wir The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU.
Catalog Number
-
Brand Name
SoundBite® Curving Tool 14
Version/Model Number
900-0001291
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2021
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
K210839,K210839
Product Code
PDU
Product Code Name
Catheter For Crossing Total Occlusions
Public Device Record Key
fcef0dea-7f67-4975-83cf-ee5b047473ca
Public Version Date
June 30, 2021
Public Version Number
3
DI Record Publish Date
April 30, 2021
Package DI Number
20754026505028
Quantity per Package
5
Contains DI Package
10754026505021
Package Discontinue Date
June 30, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |