DEVICE: Multi-Snare® (04046964349379)
Device Identifier (DI) Information
Multi-Snare®
612974
Not in Commercial Distribution
612974
B BRAUN INTERVENTIONAL SYSTEMS, INC
612974
Not in Commercial Distribution
612974
B BRAUN INTERVENTIONAL SYSTEMS, INC
MULTI-SNARE 15MMX125CM W/5FRX105CM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Intravascular catheter-snare | A sterile, flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)]. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXE | CATHETER, EMBOLECTOMY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K011783 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: ROOM TEMP AWAY FROM SUNLIGHT |
Special Storage Condition, Specify: KEEP DRY |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
52e2bcc0-15bc-4d3f-99b2-e9afc52237a7
July 06, 2018
4
August 09, 2016
July 06, 2018
4
August 09, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com