FDA.reportPublic FDA data

Re-Entry Malecot Nephrostomy Catheter Set

Primary DI
08714729005308
Brand
Re-Entry Malecot Nephrostomy Catheter Set
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0064101060
Device description
Re-Entry Malecot Nephrostomy Catheter Set
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
GBOCATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBOCatheter, Nephrostomy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729005308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729005308087147290053088714729005308

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506063191OPAL HDx™M004OPAL14010M004OPAL140102026-10-28
08714729840442SYNERGY™H7493926108220H74939261082202016-01-14
08714729840459SYNERGY™H7493926108250H74939261082502016-01-14
08714729840466SYNERGY™H7493926108270H74939261082702016-01-14
08714729840473SYNERGY™H7493926108300H74939261083002016-01-14
08714729840480SYNERGY™H7493926108350H74939261083502016-01-14
08714729840497SYNERGY™H7493926108400H74939261084002016-01-14
08714729840503SYNERGY™H7493926112220H74939261122202016-01-14
08714729840510SYNERGY™H7493926112250H74939261122502016-01-14
08714729840527SYNERGY™H7493926112270H74939261122702016-01-14
08714729840534SYNERGY™H7493926112300H74939261123002016-01-14
08714729840541SYNERGY™H7493926112350H74939261123502016-01-14
08714729840558SYNERGY™H7493926112400H74939261124002016-01-14
08714729840565SYNERGY™H7493926116220H74939261162202016-01-14
08714729840572SYNERGY™H7493926116250H74939261162502016-01-14
08714729840589SYNERGY™H7493926116270H74939261162702016-01-14
08714729840596SYNERGY™H7493926116300H74939261163002016-01-14
08714729840602SYNERGY™H7493926116350H74939261163502016-01-14
08714729840619SYNERGY™H7493926116400H74939261164002016-01-14
08714729840626SYNERGY™H7493926120220H74939261202202016-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886333006151Skater Nephrostomy Drainage CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
00886333006168Skater Nephrostomy Drainage CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
00886333006175Skater Nephrostomy Drainage CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
00886333006182Skater Nephrostomy Drainage CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
00886333006199Skater Nephrostomy CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
15051684011587Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011594Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011600Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011617Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011624Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011631Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011648Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011655Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011662Total AbscessionAngiodynamics, Inc.GBO2024-10-30
00812261011806allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012308allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012315allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261019222allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012292allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-08
00812261012285allDrainALLWIN MEDICAL DEVICES, INC.GBO2023-07-28
00817640021339Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640021346Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020486Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2022-04-27
00817640020493Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2022-04-27
00817640020998GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-27
00817640021643GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-27
H862MPL2T1230H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862MPLT21430H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862GPJT0620H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPJT0825H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09