Perouse Medical

FDA Filings

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

FDA Registration(s)

• Registration Number: 3010872792
• FEI Number: 3010872792
• Name: Gordon MacFarlane
• Owner & Operator: Perouse Medical
• Contact Address: ROUTE DU MANOIR ; IVRY-LE-TEMPLE FR-60 Oise 60173 FR
• US Agent:
  • Gordon MacFarlane
  • ICONplc
  • 919 8738962
  • 215 6996288
  • Gordon.MacFarlane@iconplc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2100 Pennbrook Pkwy ; North Wales, PA 19454 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3004160911
• FEI Number: 3004160911
• Name: Gordon MacFarlane
• Owner & Operator: Perouse Medical
• Contact Address: Route du Manoir --; IVRY-LE-TEMPLE FR-60 Oise 60173 FR
• US Agent:
  • Gordon MacFarlane
  • ICONplc
  • 919 8738962
  • 215 6996288
  • Gordon.MacFarlane@iconplc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2100 Pennbrook Pkwy ; North Wales, PA 19454 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3006942524
• FEI Number: 3006942524
• Name: Gordon MacFarlane
• Owner & Operator: Perouse Medical
• Contact Address: Route du Manoir ; IVRY-LE-TEMPLE FR-60 Oise 60173 FR
• US Agent:
  • Gordon MacFarlane
  • ICONplc
  • 919 8738962
  • 215 6996288
  • Gordon.MacFarlane@iconplc.com
• Importing Logistics Registration:
  • Importer: ARROW International
  • Address: 2400 Bernville Road ; Reading, PA 19605 UNITED STATES
  • Phone: 1 800 5238446
  • FAX: 1 610 3780131
  • Importer Type: Retailer
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2100 Pennbrook Pkwy ; North Wales, PA 19454 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 33661234025214 PEROUSE MEDICAL	PEROUSE MEDICAL VPEE63101DP	2024-11-19
GUDID 33661234025207 PEROUSE MEDICAL	PEROUSE MEDICAL VPEE63101DN	2024-04-17
GUDID 43661234025235 PEROUSE MEDICAL	PEROUSE MEDICAL VPEE63101EA	2024-04-03
GUDID 43661234025198 PEROUSE MEDICAL	PEROUSE MEDICAL VPEE63101DM	2024-04-03
GUDID 43661234025228 PEROUSE MEDICAL	PEROUSE MEDICAL VPEE63101DR	2024-03-28
GUDID 33661234025245 PEROUSE MEDICAL	PEROUSE MEDICAL VPEE63101EB	2024-03-28
GUDID 33661234025184 PEROUSE MEDICAL	PEROUSE MEDICAL VPEE63101DL	2024-03-28
GUDID 33661234025269 PEROUSE MEDICAL	PEROUSE MEDICAL VPEE63101DS	2024-03-22
GUDID 33661234025252 PEROUSE MEDICAL	PEROUSE MEDICAL VPEE63101EC	2024-03-22
GUDID 13661234014269 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014252 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014245 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014238 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014221 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014214 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014207 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014191 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014184 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014177 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014160 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014153 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014146 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014139 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014122 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014115 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014108 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014092 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014085 PEROUSE MEDICAL	POLPERF SAFE	2021-01-08
GUDID 13661234014078 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014061 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014054 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014047 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014030 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014023 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014016 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234014009 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234013996 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234013989 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234013972 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234013965 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234013958 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234013941 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234013934 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234013927 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234013910 PEROUSE MEDICAL	POLYPERF SAFE	2021-01-08
GUDID 13661234011510 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011503 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011497 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011480 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011473 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011466 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011459 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011442 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011435 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011428 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011411 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011404 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011398 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011381 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011374 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011367 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011350 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011343 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011336 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011329 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011312 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011305 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011299 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011282 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011275 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011268 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011251 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011244 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011237 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011220 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011213 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011206 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011190 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011183 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011176 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 13661234011169 PEROUSE MEDICAL	PPS PI	2021-01-08
GUDID 23661234017533 PEROUSE MEDICAL	DOLPHIN	2020-05-06
GUDID 23661234017526 PEROUSE MEDICAL	DOLPHIN	2020-05-06
GUDID 23661234017366 PEROUSE MEDICAL	CALIBER	2020-05-06
GUDID 13661234017437 PEROUSE MEDICAL	INFLATION SYSTEM	2020-05-06
GUDID 13661234017659 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017635 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017628 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017611 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017604 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017598 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017581 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017574 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017567 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017550 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234017543 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234011541 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234011534 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 13661234011527 PEROUSE MEDICAL	Polysite	2019-10-23
GUDID 03661234017645 PEROUSE MEDICAL	Polysite	2019-10-23
PMN K042449 | MAV Gordon MacFarlane [Perouse Medical]	Dolphin Inflation Device	2017-01-11
LXH Gordon MacFarlane [Perouse Medical]	Inflation System	2015-04-01
LXH Gordon MacFarlane [Perouse Medical]	Inflation System	2015-04-01
HNW Gordon MacFarlane [Perouse Medical]	Flamingo Inflation Device	2015-02-02
HNW Gordon MacFarlane [Perouse Medical]	Flamingo Inflation Device	2014-11-18
PMN K123035 | DXC Gordon MacFarlane [Perouse Medical]	SEAL ONE? Radial Compression Device	2014-11-13
PMN K080472 | DTL Gordon MacFarlane [Perouse Medical]	MyShell Lite	2014-11-13
PMN K042449 | MAV Gordon MacFarlane [Perouse Medical]	Dolphin Inflation Device	2014-11-13
PMN K063631 | FPA Gordon MacFarlane [Perouse Medical]	POLYPERF without injection site	2014-08-01
PMN K063631 | FPA Gordon MacFarlane [Perouse Medical]	POLYPERF with injection site	2014-08-01
PMN K063631 | FPA Gordon MacFarlane [Perouse Medical]	POLYPERF SAFE without injection site	2014-08-01
PMN K063631 | FPA Gordon MacFarlane [Perouse Medical]	POLYPERF SAFE with injection site	2014-08-01
PMN K063631 | FMI Gordon MacFarlane [Perouse Medical]	POLYPERF without injection site	2014-08-01
PMN K063631 | FMI Gordon MacFarlane [Perouse Medical]	POLYPERF with injection site	2014-08-01
PMN K063631 | FMI Gordon MacFarlane [Perouse Medical]	POLYPERF SAFE without injection site	2014-08-01
PMN K063631 | FMI Gordon MacFarlane [Perouse Medical]	POLYPERF SAFE with injection site	2014-08-01
PMN K120261 | FPA Gordon MacFarlane [Perouse Medical]	PPS PI? Pressure Injectable Safety Huber Needle	2014-04-24
PMN K120261 | FMI Gordon MacFarlane [Perouse Medical]	PPS PI? Pressure Injectable Safety Huber Needle	2014-04-24
PMN K122834 | OKE Gordon MacFarlane [Perouse Medical]	POLYSITE Implantable Infusion Port	2013-12-17
PMN K122834 | LJT Gordon MacFarlane [Perouse Medical]	POLYSITE Implantable Infusion Port	2013-12-17
PMN K122834 Perouse Medical	POLYSITE IMPLANTABLE INFUSION PORTS	2013-12-11
PMN K123035 | DXC Gordon MacFarlane [Perouse Medical]	SEAL ONE? Radial Compression Device	2013-01-30
PMN K120261 | FPA Gordon MacFarlane [Perouse Medical]	PPS PI? Pressure Injectable Safety Huber Needle	2013-01-30
PMN K120261 | FMI Gordon MacFarlane [Perouse Medical]	PPS PI? Pressure Injectable Safety Huber Needle	2013-01-30
PMN K123035 Perouse Medical	SEAL ONE	2012-11-28
PMN K120261 Perouse Medical	PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER	2012-05-02
GDF Gordon MacFarlane [Perouse Medical]	STERILE NEEDLE GUIDE	2010-04-19
PMN K080472 | DTL Gordon MacFarlane [Perouse Medical]	MyShell Lite	2008-09-11
PMN K042449 | MAV Gordon MacFarlane [Perouse Medical]	Dolphin Inflation Device	2008-09-11
PMN K063631 | FPA Gordon MacFarlane [Perouse Medical]	POLYPERF	2008-02-05
PMN K063631 | FPA Gordon MacFarlane [Perouse Medical]	POLYPERF Safe	2008-02-05
PMN K063631 | FMI Gordon MacFarlane [Perouse Medical]	POLYPERF	2008-02-05
PMN K063631 | FMI Gordon MacFarlane [Perouse Medical]	POLYPERF Safe	2008-02-05

Related Finance Registrations

NCAGE Code	FAVT8	PEROUSE MEDICAL
NCAGE Code	F4987	PEROUSE MEDICAL
CAGE Code	F4987	PEROUSE MEDICAL
CAGE Code	FAVT8	PEROUSE MEDICAL