DEVICE: CP Stent™ (04046964898969)
Device Identifier (DI) Information
CP Stent™
614315
In Commercial Distribution
614315
B BRAUN INTERVENTIONAL SYSTEMS, INC
614315
In Commercial Distribution
614315
B BRAUN INTERVENTIONAL SYSTEMS, INC
MCP004 Mounted CP Stent 2.2 12 2.5 8F
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 |
---|---|
Bare-metal aortic stent | A sterile non-bioabsorbable tubular device intended to be implanted in 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 made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. 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) : 12.000 MM |
Device Size Text, specify: Length : 22.000 MM |
Device Record Status
f565dae4-b7dc-4071-bf0b-12f1e05d9ba7
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