FDA.reportPublic FDA data

Remotely Operated Suction & Irrigation Tubing Set, Box

Primary DI
10817122020031
Brand
Remotely Operated Suction & Irrigation Tubing Set, Box
Company
VASCULAR TECHNOLOGY, INCORPORATED
Model
106410
Catalog number
106410
Device description
Part Number 106410, Remotely Operated Suction Irrigation Tubing Set, Box
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
10817122020031PrimaryGS10
00817122020034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712202003110817122020031
00817122020034008171220200348171220200340817122020034

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
161989343
Device count
7
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration 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

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Primary DI, Brand, Company table
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04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
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