FDA.reportPublic FDA data

Formula 418

Primary DI
10827002566092
Brand
Formula 418
Company
COOK INCORPORATED
Model
G56609
Catalog number
FOR418-18-80-5-16
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
10827002566092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700256609210827002566092

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
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08717648078200Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21