FDA.reportPublic FDA data

Percutaneous Tract Kit

Primary DI
08714729784432
Brand
Percutaneous Tract Kit
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0064501140
Device description
Percutaneous Tract Kit
Published
2017-09-24
Public version status
Update
Distribution status
Not 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
OFCCatheter introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFCCatheter Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729784432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729784432087147297844328714729784432

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956349537CARDINAL HEALTHCardinal Health 200, LLCOFC2026-02-20
50198956349535CARDINAL HEALTHCardinal Health 200, LLCOFC2026-02-20
00850001105125Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.OFC2024-10-16
B090LRKIT0Landmark Catheter Introducer KitZIEN MEDICAL TECHNOLOGIES, INC.OFC2024-04-24
B090LRKIT1Landmark Catheter Introducer KitZIEN MEDICAL TECHNOLOGIES, INC.OFC2024-04-24
10197106117118CARDINAL HEALTHCardinal Health 200, LLCOFC2023-02-03
50197106117116CARDINAL HEALTHCardinal Health 200, LLCOFC2023-02-03
10197106093665CARDINAL HEALTHCardinal Health 200, LLCOFC2023-01-09
10197106080092CARDINAL HEALTHCardinal Health 200, LLCOFC2023-01-03
00863092000101Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.OFC2022-12-15
10195594801823CARDINAL HEALTHCardinal Health 200, LLCOFC2022-11-09
50195594801821CARDINAL HEALTHCardinal Health 200, LLCOFC2022-11-09
10195594759643CARDINAL HEALTHCardinal Health 200, LLCOFC2022-07-25
50195594759641CARDINAL HEALTHCardinal Health 200, LLCOFC2022-07-25
10195594498221CARDINAL HEALTHCardinal Health 200, LLCOFC2022-01-04
50195594498229CARDINAL HEALTHCardinal Health 200, LLCOFC2022-01-04
10195594958237CARDINAL HEALTHCardinal Health 200, LLCOFC2021-03-08
50195594958235CARDINAL HEALTHCardinal Health 200, LLCOFC2021-03-08
10195594926137CARDINAL HEALTHCardinal Health 200, LLCOFC2021-02-11
50195594926135CARDINAL HEALTHCardinal Health 200, LLCOFC2021-02-11
10888439821550CARDINAL HEALTHCardinal Health 200, LLCOFC2020-04-24
50888439821558CARDINAL HEALTHCardinal Health 200, LLCOFC2020-04-24
10888439783827CARDINAL HEALTHCardinal Health 200, LLCOFC2020-03-24
50888439783825CARDINAL HEALTHCardinal Health 200, LLCOFC2020-03-24
10888439448115CARDINAL HEALTHCardinal Health 200, LLCOFC2019-04-08
50888439448113CARDINAL HEALTHCardinal Health 200, LLCOFC2019-04-08
10888439400151CARDINAL HEALTHCardinal Health 200, LLCOFC2019-03-01
50888439400159CARDINAL HEALTHCardinal Health 200, LLCOFC2019-03-01
10888439076431CARDINAL HEALTHCardinal Health 200, LLCOFC2018-08-01
10887488724782CARDINAL HEALTHCardinal Health 200, LLCOFC2017-05-17