FDA.reportPublic FDA data

Formula 418

Primary DI
10827002566252
Brand
Formula 418
Company
COOK INCORPORATED
Model
G56625
Catalog number
FOR418-18-135-6-12
Device description
Formula 418, Renal Balloon-Expandable Stent
Published
2014-09-24
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
NINSTENT, RENAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NINStent, RenalUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002566252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700256625210827002566252

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal renal artery stentA non-bioabsorbable tubular device intended to be implanted in a renal artery to maintain arterial patency and improve luminal diameter in patients with symptomatic atherosclerotic disease. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, sometimes bifurcation (Y-shaped) design, and is typically delivered to the site of implantation with a balloon catheter which will expand the device upon balloon inflation. It is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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