NINEPOINT MEDICAL, INC.

Matched from indexed company URL: NinePoint Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3008805841	3008805841	NINEPOINT MEDICAL, INC.	1	N	2020-04-25	12 Oak Park Dr Bedford MA US 01730

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00859591006027	NvisionVLE Imaging Probe 14mm - 95101-14	855-900-7195	customerservice@ninepointmedical.com
00859591006034	NvisionVLE Imaging Probe 17mm - 95101-17	855-900-7196	customerservice@ninepointmedical.com
00859591006041	NvisionVLE Imaging Probe 20mm - 95101-20	855-900-7197	customerservice@ninepointmedical.com
00859591006232	NvisionVLE Inflation Kit - 96101-60	855-900-7206	customerservice@ninepointmedical.com
00859591006249	NvisionVLE Marking Console with IRIS - 94301-MI	855-900-7202	customerservice@ninepointmedical.com
00859591006256	NvisionVLE Marking Console with IRIS, Refurbished - 94301-MI-R	855-900-7202	customerservice@ninepointmedical.com
00859591006263	NvisionVLE Marking Console with IRIS, Upgraded - 94301-MI-UPG	855-900-7202	customerservice@ninepointmedical.com
00859591006270	NvisionVLE Marking Console with IRIS, Upgraded, Refurbished - 94301-MI-UPG-R	855-900-7202	customerservice@ninepointmedical.com

ninepointmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
141101	1360319723	K191117	NvisionVLE Low-profile Optical Probe	NQQ	2019-07-19
141101	1331986043	K182616	NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System	NQQ	2018-11-02
141101	1612437682	K182261	NvisionVLE Imaging System, NvisionVLE Optical Probe	NQQ	2018-10-16
141101	2009853104	K153479	NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System	NQQ	2016-02-16
141101	1177397493	K143678	NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory	NQQ	2015-02-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NQQ	5	2019-07-19

PMN#

NvisionVLE Low-profile Optical Probe

2019-07-19

NinePoint Medical, Inc

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

2018-11-02

NinePoint Medical, Inc.

NvisionVLE Imaging System, NvisionVLE Optical Probe

2018-10-16

NinePoint Medical, Inc.

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm Balloon, NvisionVLE Marking Probe, 17mm Balloon,NvisionVLE Marking Probe, 14mm Balloon, NvisionVLE Inflation System

2016-02-16

NINEPOINT MEDICAL, INC

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory

2015-02-06

NINEPOINT MEDICAL, INC.

NVISION VLE IMAGING SYSTEM

2013-04-25

NINEPOINT MEDICAL, INC.

NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER

2012-07-25

NINEPOINT MEDICAL, INC

NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER

2011-12-16

NINEPOINT MEDICAL, INC

GUDID#

NvisionVLE Inflation Kit - 96101-60

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Console with IRIS - 94301-MI

NINEPOINT MEDICAL, INC.

2018-11-09

NvisionVLE Marking Console with IRIS, Refurbished - 94301-MI-R

NINEPOINT MEDICAL, INC.

2018-11-09

NvisionVLE Marking Console with IRIS, Upgraded - 94301-MI-UPG

NINEPOINT MEDICAL, INC.

2018-11-09

NvisionVLE Marking Console with IRIS, Upgraded, Refurbished - 94301-MI-UPG-R

NINEPOINT MEDICAL, INC.

2018-11-09

NvisionVLE Imaging Probe 14mm - 95101-14

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Imaging Probe 17mm - 95101-17

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Imaging Probe 20mm - 95101-20

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Probe 14mm - 95301-M-14

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Probe 17mm - 95301-M-17

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Probe 20mm - 95301-M-20

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Imaging Console - 94101

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Imaging Console Refurbished - 94101-R

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Console - 94301-M

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Console Refurbished - 94301-M-R

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Probe 17mm Clinical - 95301-M-17C

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Probe 20mm Clinical - 95301-M-20C

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Probe 14mm Clinical - 95301-M-14C

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Imaging Probe 17mm Clinical - 95101-17C

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Imaging Probe 20mm Clinical - 95101-20C

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Imaging Probe 14mm Clinical - 95101-14C

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Low Profile Imaging Probe, 0mm Working Distance - 95501-LP

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Low Profile Imaging Probe, 14mm Working Distance - 95501-14

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Low Profile Imaging Probe, 20mm Working Distance - 95501-20

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Imaging System with Targeted Biopsy - Upgrade - 94301-M-UPG

NINEPOINT MEDICAL, INC.

2016-09-22

NvisionVLE Marking Upgrade Refurbished - 94301-M-UPG-R

NINEPOINT MEDICAL, INC.

2016-09-22