Duns Number:097736867
Device Description: Multi-Snare Set 10mm x 125cm
Catalog Number
612973
Brand Name
BBraun Multi-Snare
Version/Model Number
612973
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
K011783,K011783,K011783,K011783
Product Code
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
ce3f2a61-4077-4448-a5a1-e5f819026677
Public Version Date
July 08, 2021
Public Version Number
4
DI Record Publish Date
September 29, 2016
Package DI Number
30813623011299
Quantity per Package
1
Contains DI Package
00813623011298
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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 109 |