FDA.reportPublic FDA data

Flexima™ APDL

Primary DI
08714729191759
Brand
Flexima™ APDL
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001271320
Device description
Drainage Catheter System
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FFATUBE, DRAINAGE, SUPRAPUBIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFATube, Drainage, SuprapubicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729191759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729191759087147291917598714729191759

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheterA sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00792293985095Uro-Kit® Reusable Latex Leg Bag System 9 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985101Uro-Kit® Reusable Latex Leg Bag System 10 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985163Uro-Kit® Reusable Latex Leg Bag System 16 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985187Uro-Kit® Reusable Latex Leg Bag System 18 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985262Uro-Kit® Reusable Latex Leg Bag System 26 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985323Uro-Kit® Reusable Latex Leg Bag System 32 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293995100Uro-Kit® Reusable Latex Leg Bag System 10 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293995162Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.)UROCARE PRODUCTS, INC.FFA2018-04-09
00792293995261Uro-Kit® Reusable Latex Leg Bag System 26 oz.UROCARE PRODUCTS, INC.FFA2018-04-09
00792293995322Uro-Kit® Reusable Latex Leg Bag System 32 oz.UROCARE PRODUCTS, INC.FFA2018-04-09
00792293995445Uro-Kit® Reusable Latex Leg Bag System 44 oz.UROCARE PRODUCTS, INC.FFA2018-04-09
08714729127970Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191766Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191773Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191780Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191797Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191803Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191810Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191827Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729271369Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729271376Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729271383Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729300670Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729300694Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323044Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323051Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323068Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323075Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323082Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323099Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24