FDA.reportPublic FDA data

Optiflo

Primary DI
08714729745242
Brand
Optiflo
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00511750
Device description
Hemostasis Catheter
Published
2016-09-24
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
FBKendoscopic injection needle, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729145264PackageGS15Not in Commercial Distribution
08714729745242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729145264087147291452648714729145264
08714729745242087147297452428714729745242

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. 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
Device Size Text, specify0

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
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
10850002461388InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461395InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461418InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461425InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
00850002461404InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
00850002461435InjecSURE®Carbon Medical Technologies, Inc.FBK2026-04-09
03600040326893BoNeeColoplast A/SFBK2025-05-20
03600040974841BoNeeColoplast A/SFBK2025-05-20
00816734023365EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023372EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023389EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023396EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816207021256AcuJect FlexENDO-THERAPEUTICS, INC.FBK2023-07-11
04953170454011Single Use InjectorOLYMPUS MEDICAL SYSTEMS CORP.FBK2023-04-29
04953170454028Single Use InjectorOLYMPUS MEDICAL SYSTEMS CORP.FBK2023-04-29
04953170454035Single Use InjectorOLYMPUS MEDICAL SYSTEMS CORP.FBK2023-04-29
00860008483720Uro-N CystoscopeUROVIU CORP.FBK2022-12-16
00724995219185FastFloUS EndoscopyFBK2022-11-09
00724995219192FastFloUS EndoscopyFBK2022-11-09
00724995219208FastFloUS EndoscopyFBK2022-11-09
00724995219215FastFloUS EndoscopyFBK2022-11-09
00724995180881NAUS EndoscopyFBK2020-04-02
00724995180898NAUS EndoscopyFBK2020-04-02
00724995180904NAUS EndoscopyFBK2020-04-02
00724995180911NAUS EndoscopyFBK2020-04-02
00724995180928NAUS EndoscopyFBK2020-04-02
00724995180935NAUS EndoscopyFBK2020-04-02
00724995180942NAUS EndoscopyFBK2020-04-02
00724995180850ArticulatorUS EndoscopyFBK2020-04-01
00724995180867ArticulatorUS EndoscopyFBK2020-04-01