Systagenix Wound Management Manufacturing L T D

FDA Filings

This page includes the latest FDA filings for Systagenix Wound Management 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 Number3007663067
FEI Number3007663067
NameSamuel Hatcher
Owner & OperatorSystagenix Wound Management Manufacturing Limited
Contact AddressAirebank Mill, Gargrave
North Yorkshire GB-NYK North Yorkshire BD23 3RX GB
Official Correspondent
  • John E Greenham
  • 44-1756-747255-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5900 Middle View Way
Knoxville, TN 37909 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device
Company
DeviceDate
Samuel Hatcher [Systagenix Wound Management Manufacturing Limited]
CVS Manuka Bandage2020-03-06
Samuel Hatcher [Systagenix Wound Management Manufacturing Limited]
FlexPasser Tendon Retrieval Kit2019-12-04
Samuel Hatcher [Systagenix Wound Management Manufacturing Limited]
Fastlok2019-11-25
Samuel Hatcher [Systagenix Wound Management Manufacturing Limited]
Infinity-Lock Button System2019-11-25
Samuel Hatcher [Systagenix Wound Management Manufacturing Limited]
Secure-Loop2019-11-25
Samuel Hatcher [Systagenix Wound Management Manufacturing Limited]
Poly-Tapes plus Fastloks2019-11-25
Samuel Hatcher [Systagenix Wound Management Manufacturing Limited]
Ortho Tape, Poly Tape2019-11-25
Samuel Hatcher [Systagenix Wound Management Manufacturing Limited]
CC-Hook2019-11-25

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