Purple Surgical Manufacturing L T D

FDA Filings

This page includes the latest FDA filings for Purple Surgical Manufacturing 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 Number: 3008571754
• FEI Number: 3008571754
• Name: Purple Surgical Manufacturing Limited
• Owner & Operator: Purple Surgical International Limited
• Contact Address: 2 Chestnut House Farm Close, Shenley; Herts GB-ENG England WD7 9AD GB
• Official Correspondent:
  • Glen Hillsley
  • 44-1923-839333-x
• US Agent:
  • Alan Schwartz
  • 516 4829001
  • alan@mdiconsultants.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Culmhead Business Centre Culmhead; Taunton Somerset, TA3 7DY GB
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
NNI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS6901	2019-11-19
NNI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS6666	2019-11-19
NNI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS6183	2019-11-19
NNI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS6181	2019-11-19
NNI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS6000C	2019-11-19
NNI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS6000B	2019-11-19
NNI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS6000	2019-11-19
PMN K993604 | OCT Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Mr. Clear	2019-05-08
PMN K033880 | GEI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	ElectroLube	2019-05-08
GAZ Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS6100	2016-11-08
PMN K142868 | GEI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Monopolar Cables	2014-12-04
PMN K142868 | GEI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	5mm Laparoscopic Electrodes	2014-12-04
KZD Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS3871 Irrigation Pump	2012-04-24
GAA Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Various names and Models	2011-03-15
GAA Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Aspiration Needle (PS3895)	2011-03-15
PMN K022503 | LKF Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Uterine Manipulator - Various names and models	2010-12-01
PMN K022503 | LKF Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS3111	2010-12-01
NKC Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS3600, PS3601, PS3602, PS3603, PS3604, PS3605	2010-12-01
NKC Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Insufflation Filter Tubing Sets - Various names and models	2010-12-01
KQM Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS3900	2010-12-01
KQM Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Camera Sleeve - Various names and models	2010-12-01
KGY Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Tissue Retrieval Pouches - Various names and models	2010-12-01
KGY Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS3400, PS3401	2010-12-01
KGY Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Endo Retrieval Pouches - Various names and models	2010-12-01
GDI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	PS3885, PS3886 Various names and models	2010-12-01
GDI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Laparoscopic Blunt Tip Disector 5 x 41cm Single Use	2010-12-01
PMN K081398 | HET Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Purple Surgical International Ltd Disposable Trocar	2010-09-13
PMN K081398 | HET Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Model Number: PS3852ULT	2010-09-13
PMN K081398 | HET Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	& Laparascopic Accessories	2010-09-13
PMN K081398 | GEI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Purple Surgical International Ltd Disposable Trocar	2010-09-13
PMN K081398 | GEI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Model Number: PS3852ULT	2010-09-13
PMN K081398 | GEI Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	& Laparascopic Accessories	2010-09-13
PMN K081398 | GCJ Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Purple Surgical International Ltd Disposable Trocar	2010-09-13
PMN K081398 | GCJ Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	Model Number: PS3852ULT	2010-09-13
PMN K081398 | GCJ Purple Surgical Manufacturing Limited [Purple Surgical International Limited]	& Laparascopic Accessories	2010-09-13