FDA.reportPublic FDA data

NaviGuide

Primary DI
08714729953395
Brand
NaviGuide
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0067001340
Device description
Percutaneous Access Needle
Published
2017-10-12
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
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
08714729953395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729953395087147299533958714729953395

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheter introduction needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access the kidney during nephrostomy catheter introduction for urinary drainage. It is intended to enable introduction of a guidewire (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. It may include an intraluminal stylet intended to add rigidity to the needle during introduction. 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

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
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

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Primary DI, Brand, Company table
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15051684011648Total AbscessionAngiodynamics, Inc.GBO2024-10-30
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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
00817640020103Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020110Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020202Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020097GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-29
00817640020219GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-29
00817640020035GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020042GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020066GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020073GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020080GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020059GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-26
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