FDA.reportPublic FDA data

NA

Primary DI
08714729295860
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001482500
Device description
Fascial Dilator
Published
2016-09-19
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
GCCDilator, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCCDilator, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729115670PackageGS110In Commercial Distribution
08714729295860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729115670087147291156708714729115670
08714729295860087147292958608714729295860

GMDN Terms#

Term, Definition table
TermDefinition
Fascial tissue dilator, single-useA surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

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
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450440476ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440483ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440506ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440513ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440520ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440537ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440568ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440575ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440582ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440599ByrdMerit Medical Systems, Inc.GCC2026-08-21
B382SD916130120Surgical DirectSurgical Direct, Inc.GCC2026-07-28
00810212930404SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930411SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930428SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930435SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930442SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930459SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933504SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933511SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933528SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933535SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933542SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933559SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933566SURGIPROSSurgipros, LLCGCC2026-05-28
00850007350338Salivary Access Dilator SetC2DX, INC.GCC2026-02-10
00194613099848MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2025-08-01
00194613094942MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2024-08-15
00840183501945BR Surgical, LLCBR Surgical, LLCGCC2024-01-31
G586UR96282190Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282210Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18