DEVICE: CP Stent™ (04046964899379)
Device Identifier (DI) Information
CP Stent™
614357
In Commercial Distribution
614357
B BRAUN INTERVENTIONAL SYSTEMS, INC
614357
In Commercial Distribution
614357
B BRAUN INTERVENTIONAL SYSTEMS, INC
CMCP008 Mounted Covered CP Stent 2.8 14
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
43583 | General aorta endovascular stent-graft |
A 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PNF | Aortic stent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P150028 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT |
Storage Environment Temperature: between 5 and 45 Degrees Celsius |
Special Storage Condition, Specify: |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Diameter (mm) : 14.000 MM |
Device Size Text, specify: Length : 28.000 MM |
Device Record Status
6b2c61e0-7b56-4591-a201-307527d4b912
September 07, 2023
8
May 19, 2016
September 07, 2023
8
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