Purple Surgical I N T L T D

FDA Filings

This page includes the latest FDA filings for Purple Surgical I N T L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008439467
FEI Number3008439467
NameAlan Schwartz
Owner & OperatorPurple Surgical International Limited
Contact Address2 Chestnut House Farm Close, Shenley
Herts GB-ENG England WD7 9AD GB
Official Correspondent
  • Glen Hillsley
  • 44-1923-839333-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address55 Northern Blvd., Suite 200
Great Neck, NY 11021 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device



Registration Number3008571754
FEI Number3008571754
NamePurple Surgical Manufacturing Limited
Owner & OperatorPurple Surgical International Limited
Contact Address2 Chestnut House Farm Close, Shenley
Herts GB-ENG England WD7 9AD GB
Official Correspondent
  • Glen Hillsley
  • 44-1923-839333-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressCulmhead Business Centre Culmhead
Taunton Somerset, TA3 7DY GB
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal Threaded Cannula PS5577ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Threaded cannula + Additional Cannula PS5576ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Threaded cannula, PS5575ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal Threaded Cannula PS5568ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal Threaded Cannula PS5567ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal Threaded Cannula PS5566ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Threaded cannula PS5565ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Threaded cannula + Additional Cannula PS5564ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Threaded cannula, PS5562ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Threaded cannula + Additional Cannula PS5561ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating Tip Trocar with Threaded cannula + Additional Cannula PS5476ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating Tip Trocar with Threaded cannula PS5475ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating Tip Trocar with Threaded cannula PS5465ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating Tip Trocar with Threaded cannula + Additional Cannula PS5464ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating Tip Trocar with Threaded cannula + Additional Cannula PS5463ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating Tip Trocar with Threaded cannula PS5462ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating Tip Trocar with Threaded cannula + Additional Cannula PS5461ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating Tip Trocar with Threaded cannula PS5460ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal Smooth cannula PS4577ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with smooth cannula + Additional Cannula PS4576ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with smooth cannula PS4575ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal Smooth Cannula PS4568ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-Shield Trocar with smooth cannula PS4565ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-Shield Trocar with smooth cannula + Additional Cannula PS4564ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-Shield Trocar with smooth cannula + Additional Cannula PS4563ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Autoshield trocar with smooth cannula PS4562ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with smooth cannula plus extra cannula PS4561ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with smooth cannula PS4560ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dialting tip trocar with smooth cannula plus extra cannula PS4476ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dialting tip trocar with smooth cannula PS4475ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating tip trocar with smooth cannula PS4465ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating trocar with smooth cannula plus extra cannula PS4463ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating tip trocar with smooth cannula PS4462ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating tip trocar with smooth cannula plus extra cannula PS4461ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating tip trocar with smooth cannula PS4460ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Hasson Trocar with smooth cannula and fixation device PS4262ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Hasson trocar with smooth cannula and fixation device PS4260ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ribbed cannula PS35172020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating Tip Trocar with Ribbed cannula + Additional Ca PS3476ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating Tip Trocar with Ribbed cannula + Additional Cannula PS3463ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating Tip Trocar with Ribbed cannula + Additional Cannula PS3461ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Diltating tip trocar with ribbed cannula PS3475ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating Tip Trocar with Ribbed cannula PS3462ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with ribbed cannula plus additional cannula PS3576ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating Tip Trocar Kit with Ribbed cannula+ Additional Cannula PS3464ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Hasson trocar with ribbed cannula and fixation device PS3262ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Hasson Trocar with ribbed cannula and fixation device PS3260ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating tip trocar with ribbed cannula PS3465ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating tip trocar with ribbed cannula PS3460ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Universal ribbed cannula PS3577ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with ribbed cannula PS3575ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Universal ribbed cannula PS3568ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Universal ribbed cannula PS3567ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Universal Ribbed cannula PS3566ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with ribbed cannula PS3565ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with ribbed cannula plus additional cannula PS3564ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with ribbed cannula plus additional cannula PS3563ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with ribbed cannula PS3562ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with ribbed cannula plus additional cannula PS3561ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Auto-shield trocar with ribbed cannula PS3560ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal cannula PS35072020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-shield trocar, ribbed PS35052020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating tip trocar, ribbed PS34152020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Dilating tip trocar, ribbed PS34102020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Secondary trocar without Gas Port + Additional Cannula without Gas Port PS33562020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Secondary Trocar with Gas Port + Additional Cannula without Gas Port PS33552020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Secondary Trocar without gas port PS33062020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-shield trocar, ribbed cannula PS35102020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Secondary Trocar with gas port PS33072020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Hasson Trocar PS32122020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Hasson Trocar PS32102020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal cannula PS35082020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Secondary Trocar with gas port PS33052020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-shield trocar, ribbed cannula PS35152020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Threaded cannula + Additional Cannula. Plus PS5569ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with smooth cannula + Additional Cannula. plus Autoshield tro PS4569ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal Smooth Cannula PS4567ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Secondary trocar with Gas Port + Additional Cannula without Gas Port PS33572020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto Shield Trocar, Ribbed, plus extra cannula PS35162020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Ribbed Cannula, Additional Cannula. Plus 1 PS3569ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-shield trocar, ribbed cannula plus extra cannula PS35142020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-shield trocar, ribbed cannula plus additional cannula PS35132020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-shield trocar, ribbed cannulas plus extra cannulas PS35092020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto Shield Trocar Ribbed, plus extra cannula PS35182020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-shield trocar, ribbed cannula PS35122020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Threaded cannula + Additional Cannula PS5563ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Auto-Shield Trocar with Threaded cannula. PS5560ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Universal Smooth Cannula PS4566ULT2020-01-09
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Dilating tip trocar with smooth cannula plus extra cannula PS4464ULT2020-01-09
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS69012019-11-19
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS66662019-11-19
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS61832019-11-19
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS61812019-11-19
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS6000C2019-11-19
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS6000B2019-11-19
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS60002019-11-19
Alan Schwartz [Purple Surgical International Limited]
PS69012019-11-19
Alan Schwartz [Purple Surgical International Limited]
PS66662019-11-19
Alan Schwartz [Purple Surgical International Limited]
PS61832019-11-19
Alan Schwartz [Purple Surgical International Limited]
PS61812019-11-19
Alan Schwartz [Purple Surgical International Limited]
PS6000C2019-11-19
Alan Schwartz [Purple Surgical International Limited]
PS6000B2019-11-19
Alan Schwartz [Purple Surgical International Limited]
PS60002019-11-19
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Mr. Clear2019-05-08
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
ElectroLube2019-05-08
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Suction / Irrigation probe PS3835ULT2019-04-23
PURPLE SURGICAL INTERNATIONAL LIMITED
Ulimate Suction/Irrigation probe PS3845ULT2019-04-23
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Suction/Irrigation probe PS3853ULT2019-04-23
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Laparoscopic Suction/Irrigation Set, Single spike PS3851ULT2019-04-23
PURPLE SURGICAL INTERNATIONAL LIMITED
Laparoscopic Suction/ Irrigation Set single spike PS38012019-04-23
PURPLE SURGICAL INTERNATIONAL LIMITED
Laparoscopic Suction / Irrigation set dual spike PS38002019-04-23
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Laparoscopic Suction Irrigation probe, reusable PS3852ULT2019-04-23
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Laparoscopic Suction/Irrigation Set, Dual spike PS3850ULT2019-04-23
PURPLE SURGICAL INTERNATIONAL LIMITED
Laparoscopic Suction Irrigation probe, resusable PS38522019-04-23
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Monopolar Metzenbaum Scissor PS3551ULT2019-02-21
PURPLE SURGICAL INTERNATIONAL LIMITED
Ultimate Monopolar Straight Grasping Forceps with PS3556ULT2019-02-21
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS61002016-11-08
Alan Schwartz [Purple Surgical International Limited]
PS61002016-11-08
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Monopolar Cables2014-12-04
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
5mm Laparoscopic Electrodes2014-12-04
Alan Schwartz [Purple Surgical International Limited]
Monopolar Cables2014-12-04
Alan Schwartz [Purple Surgical International Limited]
5mm Laparoscopic Electrodes2014-12-04
Purple Surgical International Limited
5mm Laparoscopic Electrode With J Hook, 5mm Laparoscopic Electrode With L Hook, 5mm Laparoscopic Electrode With Spatula, Monopolar Cable With 4mm Pin, Monopolar Cable With 8mm Pin2014-11-21
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS3871 Irrigation Pump2012-04-24
Alan Schwartz [Purple Surgical International Limited]
PS3871 Irrigation Pump2012-04-24
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Various names and Models2011-03-15
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Aspiration Needle (PS3895)2011-03-15
Alan Schwartz [Purple Surgical International Limited]
Various names and Models2011-03-15
Alan Schwartz [Purple Surgical International Limited]
Aspiration Needle (PS3895)2011-03-15
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Uterine Manipulator - Various names and models2010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS31112010-12-01
Alan Schwartz [Purple Surgical International Limited]
Uterine Manipulator - Various names and models2010-12-01
Alan Schwartz [Purple Surgical International Limited]
PS31112010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS3600, PS3601, PS3602, PS3603, PS3604, PS36052010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Insufflation Filter Tubing Sets - Various names and models2010-12-01
Alan Schwartz [Purple Surgical International Limited]
PS3600, PS3601, PS3602, PS3603, PS3604, PS36052010-12-01
Alan Schwartz [Purple Surgical International Limited]
Insufflation Filter Tubing Sets - Various names and models2010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS39002010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Camera Sleeve - Various names and models2010-12-01
Alan Schwartz [Purple Surgical International Limited]
PS39002010-12-01
Alan Schwartz [Purple Surgical International Limited]
Camera Sleeve - Various names and models2010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Tissue Retrieval Pouches - Various names and models2010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS3400, PS34012010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Endo Retrieval Pouches - Various names and models2010-12-01
Alan Schwartz [Purple Surgical International Limited]
Tissue Retrieval Pouches - Various names and models2010-12-01
Alan Schwartz [Purple Surgical International Limited]
PS3400, PS34012010-12-01
Alan Schwartz [Purple Surgical International Limited]
Endo Retrieval Pouches - Various names and models2010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
PS3885, PS3886 Various names and models2010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Laparoscopic Blunt Tip Disector 5 x 41cm Single Use2010-12-01
Alan Schwartz [Purple Surgical International Limited]
PS3885, PS3886 Various names and models2010-12-01
Alan Schwartz [Purple Surgical International Limited]
Laparoscopic Blunt Tip Disector 5 x 41cm Single Use2010-12-01
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Purple Surgical International Ltd Disposable Trocar2010-09-13
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Model Number: PS3852ULT2010-09-13
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
& Laparascopic Accessories2010-09-13
Alan Schwartz [Purple Surgical International Limited]
Purple Surgical International Ltd Disposable Trocar2010-09-13
Alan Schwartz [Purple Surgical International Limited]
Model Number: PS3852ULT2010-09-13
Alan Schwartz [Purple Surgical International Limited]
& Laparascopic Accessories2010-09-13
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Purple Surgical International Ltd Disposable Trocar2010-09-13
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Model Number: PS3852ULT2010-09-13
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
& Laparascopic Accessories2010-09-13
Alan Schwartz [Purple Surgical International Limited]
Purple Surgical International Ltd Disposable Trocar2010-09-13
Alan Schwartz [Purple Surgical International Limited]
Model Number: PS3852ULT2010-09-13
Alan Schwartz [Purple Surgical International Limited]
& Laparascopic Accessories2010-09-13
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Purple Surgical International Ltd Disposable Trocar2010-09-13
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
Model Number: PS3852ULT2010-09-13
Purple Surgical Manufacturing Limited [Purple Surgical International Limited]
& Laparascopic Accessories2010-09-13
Alan Schwartz [Purple Surgical International Limited]
Purple Surgical International Ltd Disposable Trocar2010-09-13
Alan Schwartz [Purple Surgical International Limited]
Model Number: PS3852ULT2010-09-13
Alan Schwartz [Purple Surgical International Limited]
& Laparascopic Accessories2010-09-13

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020042040759Southhampton,United Kingdom -> New York/Newark Area, Newark, New JerseySURGICAL EQUIPMENT10 PKG

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