FDA.reportPublic FDA data

vanSonnenberg™ Sump

Primary DI
08714729149118
Brand
vanSonnenberg™ Sump
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001273100
Device description
Sump Catheter System Kit
Published
2016-08-05
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
08714729149118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729149118087147291491188714729149118

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526629907CanGaroo®66BC05-10066BC05-1002026-05-27
00802526629914CanGaroo®66BC04-10066BC04-1002026-05-27
00802526629921CanGaroo®66BC02-10066BC02-1002026-05-27
00802526629938CanGaroo®66BC01-10066BC01-1002026-05-27
00802526629945CanGaroo®66BC03-10066BC03-1002026-05-27
00802526630002EluPro™66BE02-10066BE02-1002026-05-27
00802526630019EluPro™66BE03-10066BE03-1002026-05-27
08714729390275Maverick™ XLH74937909401502016-09-24
08714729390282Maverick™ XLH74937909402002016-09-24
08714729390299Maverick™ XLH74937909451502016-09-24
08714729390305Maverick™ XLH74937909452002016-09-24
08714729390312Maverick™ XLH74937909501502016-09-24
08714729390329Maverick™ XLH74937909502002016-09-24
08714729390336Maverick™ XLH74937909551502016-09-24
08714729390343Maverick™ XLH74937909552002016-09-24
08714729390350Maverick™ XLH74937909601502016-09-24
08714729390367Maverick™ XLH74937909602002016-09-24
08714729739258NAM0014416602016-09-24
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28

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
08714729191759Flexima™ 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