FDA.reportPublic FDA data

Navigator™

Primary DI
00191506062576
Brand
Navigator™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0062504200
Catalog number
M0062504200
Device description
Ureteral Access Sheath Set
Published
2026-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope and accessories, flexible/rigid
FEDendoscopic access overtube, gastroenterology-urology
FGAKit, nephroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2
FGAKit, NephroscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506062576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506062576001915060625761915060625760191506062576

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526625008ACUITY™706070602026-10-15
08714729748861RX Cholangiogram KitM005711502016-09-24
08714729748878RX Cholangiogram KitM005711602016-09-24
08714729749097RX Cholangiogram KitM005714002016-09-24
08714729749110RX Cholangiogram KitM005714202016-09-24
08714729749257RX Cholangiogram KitM005715602016-09-24
08714729749295RX Cholangiogram KitM005716002016-09-24
08714729749332RX Cholangiogram KitM005716402016-09-24
08714729749394RX Cholangiogram KitM005717002016-09-24
08714729749509RX Cholangiogram KitM005718102016-09-24
08714729749615RX Cholangiogram KitM005719202016-09-24
00191506065577Ranger™H74939501400470H749395014004702026-10-14
00191506065584Ranger™H74939501400670H749395014006702026-10-14
00191506065591Ranger™H74939501400870H749395014008702026-10-14
00191506065607Ranger™H74939501401070H749395014010702026-10-14
00191506065614Ranger™H74939501401270H749395014012702026-10-14
00191506065621Ranger™H74939501401570H749395014015702026-10-14
00191506065638Ranger™H74939501402070H749395014020702026-10-14
00191506065645Ranger™H74939501400410H749395014004102026-10-14
00191506065652Ranger™H74939501400610H749395014006102026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013645120Prodeon Urethral Sheath SystemProdeon Medical, Inc.FED2026-10-07
00191506062514Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062514Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062514Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
06942804744602Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744619Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744626Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744633Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744640Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22