DEVICE: CP Stent™ (04046964899393)
Device Identifier (DI) Information
CP Stent™
614359
In Commercial Distribution
614359
B BRAUN INTERVENTIONAL SYSTEMS, INC
614359
In Commercial Distribution
614359
B BRAUN INTERVENTIONAL SYSTEMS, INC
CMCP010 Mounted Covered CP Stent 2.8 18
Device Characteristics
MR Conditional | |
No | |
No | |
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 |
---|---|
General aorta endovascular stent-graft | A sterile non-bioabsorbable tubular device intended to be implanted in a non-specific region of the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is a mesh structure made of metal (e.g., platinum, iridium) that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft). It is typically expanded in situ (e.g., balloon-expandable) and disposable devices associated with implantation may be included. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PNF | Aortic stent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 45 Degrees Celsius |
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Diameter (mm) : 18.000 MM |
Device Size Text, specify: Length : 28.000 MM |
Device Record Status
dc555765-068f-468c-834e-f7c12bb4f74f
March 29, 2018
2
May 19, 2016
March 29, 2018
2
May 19, 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