FDA.reportPublic FDA data

CP Stent™

Primary DI
04046955195152
Brand
CP Stent™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
614512
Catalog number
614512
Device description
CP8Z55 Bare CP Stent
Published
2017-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNFAortic stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNFAortic StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150028000CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)NuMED, Inc.2016-03-25PNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955195152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955195152040469551951524046955195152

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal aortic stentA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964309809Micro-Access Elite®6133406133402016-08-09
04046964309823Micro-Access Elite®6133416133412016-08-09
04046964309847Micro-Access Elite®6133426133422016-08-09
04046964309861Micro-Access Elite®6133436133432016-08-09
04046964309885Micro-Access Elite®6133446133442016-08-09
04046964309908Micro-Access Elite®6133456133452016-08-09
04046964309922Micro-Access Elite®6133466133462016-08-09
04046964309946Micro-Access Elite®6133476133472016-08-09
04046964309960Micro-Access Elite®6133486133482016-08-09
04046964309977Micro-Access Elite®6133496133492016-08-09
04046964310003Micro-Access Elite®6133506133502016-08-09
04046964310027Micro-Access Elite®6133516133512016-08-09
04046964310041Micro-Access Elite®6133526133522016-08-09
04046964310065Micro-Access Elite®6133536133532016-08-09
04046964310089Micro-Access Elite®6133546133542016-08-09
04046964310102Micro-Access Elite®6133556133552016-08-09
04046964310126Micro-Access Elite®6133566133562016-08-09
04046964310140Micro-Access Elite®6133576133572016-08-09
04046964310164Micro-Access Elite®6133586133582016-08-09
04046964310188Micro-Access Elite®6133596133592016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196852801862Minima Stent System - 6mmRENATA MEDICAL, INC.PNF2025-04-02
00196852805037Minima Stent System - 8mmRENATA MEDICAL, INC.PNF2025-04-02
04046955766932G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955766949G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767038G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767045G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767052G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767069G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767076G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767083G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767090G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767106G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767113G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767120G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767137G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767144G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767151G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767168G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767175G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767182G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767199G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767205G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767212G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767229G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767236G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767243G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767250G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767267G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767274G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767281G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07