FDA.reportPublic FDA data

NA

Primary DI
08714729012832
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0067401010
Catalog number
M0067401010
Device description
Connecting Tube for 7F through 10F Catheters
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
EYKCONNECTOR, URETERAL CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYKConnector, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729012832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729012832087147290128328714729012832

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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729424246Contour™M0061802311202015-09-24
08714729457923Percuflex™M0061453600502015-09-24
08714729460282Percuflex™ PlusM0061751980602015-09-24
08714729460398Percuflex™ PlusM0061752500602015-09-24
08714729460657Percuflex™ PlusM0061752600502015-09-24
08714729461012Percuflex™ PlusM0061752650602015-09-24
08714729766629Polaris™ UltraM0061921401902015-09-24
08714729766735Polaris™ UltraM0061921441702015-09-24
08714729766759Polaris™ UltraM0061921451202015-09-24
08714729766766Polaris™ UltraM0061921451702015-09-24
08714729766803Polaris™ UltraM0061921501902015-09-24
08714729766841Polaris™ UltraM0061921521202015-09-24
08714729766919Polaris™ UltraM0061921541702015-09-24
08714729766926Polaris™ UltraM0061921541902015-09-24
08714729776307Contour™M0061802351702015-09-24
08714729776680Contour™M0061802301802015-09-24
08714729777137Polaris™ UltraM0061921401802015-09-24
08714729777199Polaris™ UltraM0061921501802015-09-24
08714729777205Polaris™ UltraM0061921511802015-09-24
08714729777441Polaris™ LoopM0061552250902015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05906168942235Sealing Connector Y pieceWISMED PL SP Z O OEYK2025-03-17
05906168942242Sealing Connector I Piece WISMED PL SP Z O OEYK2025-03-17
05906168942259Sealing Connector T pieceWISMED PL SP Z O OEYK2025-03-17
08714729298151NABOSTON SCIENTIFIC CORPORATIONEYK2024-10-09
00724995211530UroSealUS EndoscopyEYK2022-11-28
10724995211537UroSealUS EndoscopyEYK2022-11-28
00827002142251CookCOOK INCORPORATEDEYK2020-10-02
00827002145290CookCOOK INCORPORATEDEYK2020-10-02
00827002162198CookCOOK INCORPORATEDEYK2020-10-02
00827002171077CookCOOK INCORPORATEDEYK2020-10-02
00850005780168GU TekV L V ASSOCIATES (INC)EYK2020-07-15
08714729010944NABOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010951NABOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010975ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010982ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010999ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729011002ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24