FDA.reportPublic FDA data

Latching Foot Switch for Use with 106400

Primary DI
00817122020515
Brand
Latching Foot Switch for Use with 106400
Company
VASCULAR TECHNOLOGY, INCORPORATED
Model
201202
Catalog number
201202
Device description
Part Number 201202, Foot Switch Latching Suction, for ROSI
Published
2023-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141323000VTI SUCTION IRRIGATION SYSTEMRegulatory Technology Services, LLC2014-06-04GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817122020515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817122020515008171220205158171220205150817122020515

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(603)594-9700info@vti-online.com

Regulatory Flags#

DUNS number
161989343
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817122020607ROSI with Wings, Tubing Set1066101066102026-05-12
00817122020713ROSI xT with Wings, Exchangeable Tip Tubing Set1066501066502026-05-12
00817122020577Footswitch, Muting2014502014502024-01-25
00817122020584Pole Mount2014552014552024-01-25
10817122020048VTI 20 MHz Disposable Doppler Probe, Curved Tip, Box1028021028022016-09-20
1081712202022220MHz Micro Disposable Doppler Probe1086501086502017-09-05
10817122020338Mizuho 07-150-12 20 MHz Micro Disposable Doppler Probe, box1386651386652016-09-20
00817122020065VTI Remotely Operated Suction & Irrigation System1064001064002016-09-20
10817122020192Mizuho 07-150-22 20 MHz Disposable Doppler Probe Curved Tip, Box1382301382302016-09-20
10817122020208Mizuho 07-150-10 Disposable Doppler Probe for Neurosurgery, Box1386601386602016-09-20
10817122020260Mizuho 07-150-07 Disposable Doppler Probe for Neurosurgery, Box1382001382002016-09-20
10817122020284Mizuho 07-150-21 20 MHz Disposable Doppler Probe Straight, Box1382201382202016-09-20
00817122020140Mizuho Power Supply Desktop 90-264 VAC108110-MIZUHO108110-MIZUHO2016-09-20
0081712202040907-150-08 Mizuho Doppler 8 MHz Dual Channel, AC Power128910-AC128910-AC2016-09-20
00817122020133VTI Power Cord: Hospital US108110-US108110-US2016-09-20
00817122020058VTI Power Cord: Hospital Australia108110-AUS108110-AUS2016-09-20
00817122020089VTI Power Cord: Hospital Europe108110-EUROPE108110-EUROPE2016-09-20
00817122020096VTI Power Cord: Hospital Japan108110-JAPAN108110-JAPAN2016-09-20
00817122020102VTI Power Supply Desktop 90-264 VAC108110-SUPPLY108110-SUPPLY2016-09-20
00817122020126VTI Power Cord: Hospital United Kingdom108110-UK108110-UK2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01