FDA.reportPublic FDA data

Formula

Primary DI
10827002185286
Brand
Formula
Company
William Cook Europe ApS
Model
G18528
Catalog number
FORX414-14-135-4-20
Device description
Formula 414 Rx, Renal Balloon-Expandable Stent
Published
2014-09-24
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100028001
P100028002
P100028003
P100028004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100028001FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEMCook Medical Incorporated2011-01-14NIN
P100028002FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEMCook Medical Incorporated2011-01-14NIN
P100028003FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEMCook Medical Incorporated2011-01-14NIN
P100028004FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEMCook Medical Incorporated2011-01-14NIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002185286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700218528610827002185286

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
305302119
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
00827002599109Zenith AlphaG59910ZTA2-P-46-179-W2024-12-03
00827002599123Zenith AlphaG59912ZTA2-P-46-233-W2024-12-03
00827002599154Zenith AlphaG59915ZTA2-P-40-117-W2024-12-03
00827002599185Zenith AlphaG59918ZTA2-P-40-142-W2024-12-03
00827002599215Zenith AlphaG59921ZTA2-P-40-167-W2024-12-03
00827002599239Zenith AlphaG59923ZTA2-P-40-217-W2024-12-03
00827002599260Zenith AlphaG59926ZTA2-P-42-121-W2024-12-03
00827002599321Zenith AlphaG59932ZTA2-P-42-173-W2024-12-03
00827002599352Zenith AlphaG59935ZTA2-P-42-225-W2024-12-03
00827002599383Zenith AlphaG59938ZTA2-P-44-125-W2024-12-03
00827002599413Zenith AlphaG59941ZTA2-P-44-152-W2024-12-03
00827002599444Zenith AlphaG59944ZTA2-P-44-179-W2024-12-03
00827002599475Zenith AlphaG59947ZTA2-P-44-233-W2024-12-03
00827002599505Zenith AlphaG59950ZTA2-P-46-125-W2024-12-03
00827002599567Zenith AlphaG59956ZTA2-P-24-105-W2024-12-03
00827002599581Zenith AlphaG59958ZTA2-P-24-127-W2024-12-03
00827002599604Zenith AlphaG59960ZTA2-P-26-105-W2024-12-03
00827002599659Zenith AlphaG59965ZTA2-P-28-109-W2024-12-03
00827002599697Zenith AlphaG59969ZTA2-P-28-132-W2024-12-03
00827002599727Zenith AlphaG59972ZTA2-P-28-155-W2024-12-03

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Primary DI, Brand, Company table
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