FDA.reportPublic FDA data

CP Stent™

Primary DI
04046964899669
Brand
CP Stent™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
614386
Catalog number
614386
Device description
CMCP037 Mounted Covered CP Stent 4.5 12
Published
2016-05-19
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
04046964899669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964899669040469648996694046964899669

GMDN Terms#

Term, Definition table
TermDefinition
General aorta endovascular stent-graftA 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.

Device Sizes#

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