Lemaitre Vascular Inc

FDA Filings

This page includes the latest FDA filings for Lemaitre Vascular Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQLMATDUNS 184805166
FDA Registration(s)
Registration Number1220948
FEI Number1220948
NameLEMAITRE VASCULAR, INC.
Owner & OperatorLEMAITRE VASCULAR, INC.
Contact Address63 Second Avenue --
Burlington MA 01803 US
Official Correspondent
  • Andrew Hodgkinson
  • x-781-4251664-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address63 SECOND AVENUE
BURLINGTON, MA 01803 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Lemaitre Vascular, Inc.
Eze-Sit Valvulotome TIVK20302022-07-08
LeMaitre Vascular Inc.
PhasTIPP2022-03-31
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft AMC40242021-06-28
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft AMC40222021-06-28
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft AMC40202021-06-28
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft AMC40182021-06-28
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft AMC40162021-06-28
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft AMC40142021-06-28
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft ATC12062021-06-28
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft ATC60382021-06-28
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft ATC60342021-06-28
Lemaitre Vascular, Inc.
AlboGraft Polyester Vascular Graft ATC60322021-06-28
Lemaitre Vascular, Inc.
Vesper Custom Tape 1112-212021-06-28
Lemaitre Vascular, Inc.
Latis Silicone Graft Cleaning Catheter A4GW62021-06-28
Lemaitre Vascular, Inc.
Latis Silicone Graft Cleaning Catheter A4G022021-06-28
Lemaitre Vascular, Inc.
Latis Silicone Graft Cleaning Catheter A4G002021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone OTW Embolectomy Catheter A4E092021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone OTW Embolectomy Catheter A4E082021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone OTW Embolectomy Catheter A4E072021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone OTW Embolectomy Catheter A4E062021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone OTW Embolectomy Catheter A4E052021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone OTW Embolectomy Catheter A4E042021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone OTW Embolectomy Catheter A4E032021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone OTW Embolectomy Catheter A4E022021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone OTW Embolectomy Catheter A4E012021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter A45182021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter A45682021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter A45582021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter A45542021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter A45482021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter A45452021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter A45382021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Embolectomy Catheter A4F082021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Embolectomy Catheter A4F072021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Embolectomy Catheter A4F062021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Embolectomy Catheter A4F052021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Embolectomy Catheter A4F042021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Embolectomy Catheter A4F032021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Embolectomy Catheter A4F022021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Embolectomy Catheter A4F012021-06-28
Lemaitre Vascular, Inc.
Syntel Silicone Embolectomy Catheter A4F002021-06-28
Lemaitre Vascular, Inc.
Anastoclip Atraumatic Forceps 4001-052021-06-28
Lemaitre Vascular, Inc.
AnastoClip GC 8cm (XLarge) 4008-082021-06-28
Lemaitre Vascular, Inc.
AnastoClip GC 8cm (Large) 4008-072021-06-28
Lemaitre Vascular, Inc.
AnastoClip GC 8cm (Medium) 4008-062021-06-28
Lemaitre Vascular, Inc.
AnastoClip GC 8cm (Small) 4008-052021-06-28
Lemaitre Vascular, Inc.
LifeSpan Quick Tapered ePTFE Vascular Graft QT460402021-06-28
Lemaitre Vascular, Inc.
XenoSure Biologic Pledgets PL0510R252021-06-28
Lemaitre Vascular, Inc.
XenoSure Biologic Pledgets PL0506R252021-06-28
Lemaitre Vascular, Inc.
XenoSure Biologic Pledgets PL0307R252021-06-28
Lemaitre Vascular, Inc.
XenoSure Thick Biologic Patch e10P16T2021-06-28
Lemaitre Vascular, Inc.
XenoSure Thick Biologic Patch e6P8T2021-06-28
Lemaitre Vascular, Inc.
YES Tape 1113-002021-06-28
Lemaitre Vascular, Inc.
XenoSure Biologic Patch e2.5P152021-06-28
Lemaitre Vascular, Inc.
XenoSure Biologic Patch e5P102021-06-28
Lemaitre Vascular, Inc.
XenoSure Biologic Patch 12BV252021-06-28
Lemaitre Vascular, Inc.
XenoSure Biologic Patch 5BV102021-06-28
Lemaitre Vascular, Inc.
XenoSure Biologic Patch 2.5BV152021-06-28
Lemaitre Vascular, Inc.
XenoSure Biologic Patch 12P252021-06-28
LEMAITRE VASCULAR, INC.
XenoSure Biologic Patch 5P102021-03-08
LEMAITRE VASCULAR, INC.
XenoSure Biologic Patch 2.5P152021-03-08
LEMAITRE VASCULAR, INC.
XenoSure Biologic Patch 2020-10-30
LEMAITRE VASCULAR, INC.
XenoSure Biologic Patch 2020-10-29
LEMAITRE VASCULAR, INC.
DuraSure Biologic Patch2019-10-16
LEMAITRE VASCULAR, INC.
AnastoClip GC Closure System2019-10-16
LEMAITRE VASCULAR, INC.
AnastoClip GC Closure System2019-10-16
LeMaitre Vascular Inc.
XenoSure Dura Biologic Patch2019-06-13
LEMAITRE VASCULAR, INC.
Polyurethane Dual Lumen Occlusion Catheter 5F-2L-802019-03-21
LEMAITRE VASCULAR, INC.
Polyurethane Dual Lumen Occlusion Catheter 5F-2L-402019-03-21
LEMAITRE VASCULAR, INC.
Polyurethane Dual Lumen Occlusion Catheter 4F-2L-802019-03-21
LEMAITRE VASCULAR, INC.
Polyurethane Dual Lumen Occlusion Catheter 4F-2L-402019-03-21
LEMAITRE VASCULAR, INC.
LeMaitre Aortic Occlusion Catheter e2107-812019-03-21
LEMAITRE VASCULAR, INC.
LeMaitre Aortic Occlusion Catheter 2107-812019-03-21
LEMAITRE VASCULAR, INC.
LeMaitre Aortic Occlusion Catheter e2107-802019-03-21
LEMAITRE VASCULAR, INC.
LeMaitre Aortic Occlusion Catheter 2107-802019-03-21
LEMAITRE VASCULAR, INC.
Distal Perfusion Catheter 2105-152019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Occlusion Catheter e2103-562019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Occlusion Catheter e2103-462019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Occlusion Catheter e2103-362019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Occlusion Catheter 2103-562019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Occlusion Catheter 2103-462019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Occlusion Catheter 2103-362019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Irrigation Occlusion Catheter e2102-092019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Irrigation Occlusion Catheter 2102-092019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Aortic Occlusion Catheter e2100-122019-03-21
LEMAITRE VASCULAR, INC.
Pruitt Aortic Occlusion Catheter 2100-122019-03-21
LEMAITRE VASCULAR, INC.
InvisiGrip Vein Stripper 1500-012019-01-31
LEMAITRE VASCULAR, INC.
Expandable LeMaitre Valvulotome 1096-002019-01-31
LEMAITRE VASCULAR, INC.
Expandable LeMaitre Valvulotome 1000-952019-01-31
LEMAITRE VASCULAR, INC.
Expandable LeMaitre Valvulotome e1000-902019-01-31
LEMAITRE VASCULAR, INC.
Expandable LeMaitre Valvulotome 1000-902019-01-31
LEMAITRE VASCULAR, INC.
Latis Graft Cleaning Catheter2019-01-24
LEMAITRE VASCULAR, INC.
Python OTW Embolectomy Catheter2019-01-24
LEMAITRE VASCULAR, INC.
Thrombectomy Catheter2019-01-24
LEMAITRE VASCULAR, INC.
Irrigation Catheter2019-01-24
LEMAITRE VASCULAR, INC.
Cholangiogram Catheter2019-01-24
LEMAITRE VASCULAR, INC.
Thrombectomy Catheter2019-01-24
LEMAITRE VASCULAR, INC.
Syntel Billiary Catheter2019-01-24
LEMAITRE VASCULAR, INC.
Syntel Embolectomy Catheter2019-01-24
LEMAITRE VASCULAR INC
ProCol Vascular Bioprosthesis2018-09-28
LEMAITRE VASCULAR INC
ProCol Vascular Bioprosthesis2018-09-19
LEMAITRE VASCULAR, INC.
LeMaitre Embolectomy Catheter 1601-382018-07-06
LEMAITRE VASCULAR, INC.
LeMaitre Embolectomy Catheter 1601-342018-07-06
LEMAITRE VASCULAR, INC.
LeMaitre Embolectomy Catheter 1601-282018-07-06
LEMAITRE VASCULAR, INC.
LeMaitre Embolectomy Catheter 1601-262018-07-06
LEMAITRE VASCULAR, INC.
LeMaitre Embolectomy Catheter 1601-242018-07-06
LEMAITRE VASCULAR, INC.
VascuTape Radiopaque Tape 1109-502018-07-06
LEMAITRE VASCULAR, INC.
VascuTape Radiopaque Tape 1109-202018-07-06
LEMAITRE VASCULAR, INC.
VascuTape Radiopaque Tape 1108-202018-07-06
LEMAITRE VASCULAR, INC.
VascuTape Radiopaque Tape 1102-502018-07-06
LEMAITRE VASCULAR, INC.
VascuTape Radiopaque Tape 1102-202018-07-06
LEMAITRE VASCULAR, INC.
VascuTape Radiopaque Tape 1102-002018-07-06
LEMAITRE VASCULAR, INC.
VascuTape Radiopaque Tape 1100-502018-07-06
LEMAITRE VASCULAR, INC.
VascuTape Radiopaque Tape 1100-202018-07-06
LEMAITRE VASCULAR, INC.
VascuTape Radiopaque Tape 1100-002018-07-06
LEMAITRE VASCULAR INC
ProCol Vascular Bioprosthesis2018-03-22
LeMaitre Vascular, Inc.
AnastoClip GC Closure System2018-03-08
LEMAITRE VASCULAR, INC.
ProCol Biologic Vascular Graft2016-03-18
LEMAITRE VASCULAR, INC.
Pruitt F3-S Polyurethane Carotid Shunt2016-01-22
LEMAITRE VASCULAR, INC.
Pruitt F3-S Carotid Shunt2016-01-22
LEMAITRE VASCULAR, INC.
Pruitt F3-S Polyurethane Carotid Shunt2016-01-21
LeMaitre Vascular, Inc
Pruitt F3-S Carotid Shunt2015-08-27
LEMAITRE VASCULAR, INC.
Reddick-Saye Screw Retractor2015-05-18
LEMAITRE VASCULAR, INC.
Antegrade LeMills Valvulotome2015-02-27
LEMAITRE VASCULAR, INC.
Over-the-Wire Lemaitre Valvulotome2015-02-27
LEMAITRE VASCULAR, INC.
Expandable LeMaitre Valvulotome2015-02-27
LEMAITRE VASCULAR INC
PROCOL VASCULAR BIOPROSTHESIS2014-10-31
LeMaitre Vascular, Inc.
Antegrade LeMills Valvulotome2014-10-17
LEMAITRE VASCULAR INC
PROCOL VASCULAR BIOPROSTHESIS2014-09-29
LEMAITRE VASCULAR, INC.
LeMaitre Angioscope2014-09-18
LEMAITRE VASCULAR, INC.
CI Embolectomy catheter2014-05-08
LEMAITRE VASCULAR, INC.
CI Shunt2014-05-08
LEMAITRE VASCULAR, INC.
CI shunt II2014-05-08
LEMAITRE VASCULAR, INC.
CI occlusion catheter2014-05-08
LEMAITRE VASCULAR, INC.
CI dual lumen catheter2014-05-08
LEMAITRE VASCULAR, INC.
HYDRO LeMaitre Valvulotome2014-04-29
LEMAITRE VASCULAR, INC.
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME2014-04-10
LEMAITRE VASCULAR, INC.
TRIVEX Sterilization Tray2014-04-01
LEMAITRE VASCULAR, INC.
UnBalloon Non-occlusive Modeling Catheter2014-01-13
LEMAITRE VASCULAR, INC.
UNBALLOON NON-OCCLUSION MODELING CATHETER2013-12-31
LEMAITRE VASCULAR, INC.
LeMills Valvulotome2013-11-18
LEMAITRE VASCULAR, INC.
LeMaitre 8F Occlusion Catheter2013-11-18
LEMAITRE VASCULAR, INC.
LEMAITRE 8F OCCLUSION CATHETER2013-11-06
LEMAITRE VASCULAR, INC.
LEMILLS VALVULOTOME2013-11-05
LEMAITRE VASCULAR, INC.
Trivex System2013-10-23
LEMAITRE VASCULAR, INC.
LifeSpan ePTFE Vascular Graft2013-08-09
LEMAITRE VASCULAR, INC.
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME2013-08-05
LEMAITRE VASCULAR, INC.
LIFESPAN EPTFE VASCULAR GRAFT2013-02-05
LEMAITRE VASCULAR, INC.
UNBALLOON NON-OCCLUSIVE MODELING CATHETER2012-12-14
LEMAITRE VASCULAR, INC.
XenoSure2012-11-05
LEMAITRE VASCULAR, INC.
Merit Laureate Guidewire2012-10-25
LEMAITRE VASCULAR, INC.
UnBalloon Non-occlusive Modeling Catheter (with silicone)2012-09-06
LEMAITRE VASCULAR, INC.
MollRing MultiTASC Dissection/Transection Device2012-09-06
LEMAITRE VASCULAR, INC.
MOLLRING MULTITASC2012-09-05
LEMAITRE VASCULAR INC.
UNBALLOON NON-OCCLUSIVE MODELING CATHETER2012-08-08
LEMAITRE VASCULAR, INC.
Inahara Pruitt Inlying Shunt2011-10-17
LEMAITRE VASCULAR, INC.
Pruitt Aortic Occlusion Catheter2011-10-17
LEMAITRE VASCULAR, INC.
Flexcel Shunt2011-10-17
LEMAITRE VASCULAR, INC.
Pruitt F3 Shunt2011-10-17
LEMAITRE VASCULAR, INC.
AlboGraft Vascular Graft2011-10-12
LEMAITRE VASCULAR, INC.
The UnBalloon Non-Occlusive Modeling Catheter2011-09-26
LEMAITRE VASCULAR INC.
THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER2011-09-13
LEMAITRE VASCULAR, INC.
0.035" LeMaitre Guidewire2011-08-16
LEMAITRE VASCULAR, INC.
Over-the-Wire Valvulotome (OTW-ELV)2011-08-16
LEMAITRE VASCULAR, INC.
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME2011-07-29
LEMAITRE VASCULAR, INC.
ALBOGRAFT VASCULAR PROSTHESIS2011-01-19
LEMAITRE VASCULAR, INC.
Pruitt Carotid Kit2010-12-15
LEMAITRE VASCULAR, INC.
Pruitt Carotid Kit2010-12-15
LEMAITRE VASCULAR, INC.
PRUITT CAROTID KIT2010-12-08
LEMAITRE VASCULAR, INC.
LifeSpan ePTFE Vascular Graft2010-12-02
LEMAITRE VASCULAR, INC.
LifeSpan ePTFE Vascular Graft2010-12-02
LEMAITRE VASCULAR, INC.
LifeSpan ePTFE Vascular Graft2010-12-02
LEMAITRE VASCULAR, INC.
LifeSpan ePTFE Vascular Graft2010-12-02
LEMAITRE VASCULAR, INC.
AlboSure Vascular Patch2010-10-07
LEMAITRE VASCULAR, INC.
ALBOSURE POLYESTER VASCULAR PATCH2010-09-20
LEMAITRE VASCULAR, INC.
AnastoClip GC (GripClip)2010-04-27
LEMAITRE VASCULAR, INC.
AnastoClip GC (GripClip)2010-04-27
LEMAITRE VASCULAR, INC.
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP2010-04-23
LEMAITRE VASCULAR INC
PROCOL VASCULAR BIOPROSTHESIS2010-03-23
LEMAITRE VASCULAR, INC.
AlboGraft Vascular Graft2010-01-28
LEMAITRE VASCULAR, INC.
ALBOGRAFT VASCULAR PROSTHESIS2010-01-14
LEMAITRE VASCULAR INC
PROCOL VASCULAR BIOPROSTHESIS2009-10-08
LEMAITRE VASCULAR, INC.
XenoSure2009-09-01
LEMAITRE VASCULAR, INC.
AnastoClip AC Closure System2008-01-24
LEMAITRE VASCULAR, INC.
AnastoClip AC Closure System2008-01-24
LEMAITRE VASCULAR, INC.
VCS Implantable Clip2008-01-24
LEMAITRE VASCULAR, INC.
Grice Suturing Needle2008-01-24
LEMAITRE VASCULAR, INC.
Pru-Inh Outlying Carotid Shunt2008-01-24
LEMAITRE VASCULAR, INC.
EndoHelix2008-01-24
LEMAITRE VASCULAR, INC.
Inivigrip2008-01-24
LEMAITRE VASCULAR, INC.
MollRing Cutter2007-11-28
LEMAITRE VASCULAR, INC.
EndoHelix Retrieval Device2007-11-28
LEMAITRE VASCULAR, INC.
Schubart Periscope2007-11-28
LEMAITRE VASCULAR, INC.
Martin Dissector2007-11-28
LEMAITRE VASCULAR, INC.
OZ POWER SYRINGE2007-08-31
LEMAITRE VASCULAR, INC.
LEVEREDGE CONTRAST INJECTOR2007-08-31
LEMAITRE VASCULAR, INC.
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-052007-08-29
LEMAITRE VASCULAR, INC.
Pruitt Irrigation Catheter2006-04-25
LEMAITRE VASCULAR, INC.
PRUITT BALLOON OCCLUSION CATHETER2006-04-25
LEMAITRE VASCULAR, INC.
GLOW'N TELL AND LE2005-11-18
LEMAITRE VASCULAR, INC.
DISTAL PERFUSION CATHETER2005-08-24
LEMAITRE VASCULAR, INC.
Reddick Catheter2005-06-13
LEMAITRE VASCULAR, INC.
INVISIGRIP VEIN STRIPPER2005-06-13
LEMAITRE VASCULAR, INC.
REDDICK-SAYE SCREW RETRACTOR KIT2005-06-13
LEMAITRE VASCULAR, INC.
REDDICK-SAYE RETRACTOR KIT2005-06-13
LEMAITRE VASCULAR, INC.
GRICE SUTURE NEEDLE2005-06-13
LEMAITRE VASCULAR, INC.
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)2005-05-27
LEMAITRE VASCULAR, INC.
PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-492004-12-03
LEMAITRE VASCULAR, INC.
AnastoClip Atraumatic Forceps2004-09-22
LEMAITRE VASCULAR, INC.
LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-052003-12-19
LEMAITRE VASCULAR, INC.
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)2003-08-27
LEMAITRE VASCULAR INC
PROCOL VASCULAR BIOPROSTHESIS2003-07-29
LEMAITRE VASCULAR, INC.
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER2003-01-30
LEMAITRE VASCULAR, INC.
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 23022003-01-14
LEMAITRE VASCULAR, INC.
Single Lumen Catheter2001-04-25
LEMAITRE VASCULAR, INC.
Novasil Catheter2001-04-25
LEMAITRE VASCULAR, INC.
VascuTape2001-04-25
LEMAITRE VASCULAR, INC.
OVER-THE-WIRE EMBOLECTOMY CATHETER2001-04-25
LEMAITRE VASCULAR, INC.
EXPANDABLE LEMAITRE VALVULOTOME1992-07-21

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019062012904Shanghai ,China (Mainland) -> Boston, MassachusettsANASTO CLIP AC AND VARICOSE VEIN ABLATION SYSTEM5 CTN
2019032510347Shanghai ,China (Mainland) -> Boston, MassachusettsANASTO CLIP AC AND VARICOSE VEIN ABLATION SYSTEM30 CTN
2018010317749Yarraville,Australia -> Long Beach, CaliforniaSLAC 13 CARTONS STC: MEDICAL PROSTHESIS LOADED AS 13 CARTONS AHECC: 9022.21.00 LOWEST HBL: S0003095713 CTN

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