FDA.reportPublic FDA data

GARRETT VASCULAR DILATOR

Primary DI
00192896010680
Brand
GARRETT VASCULAR DILATOR
Company
SONTEC INSTRUMENTS, INC.
Model
2700-020
Device description
GARRETT VASCULAR DILATOR SET OF 3
Published
2018-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWPDilator, Vessel, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWPDilator, Vessel, SurgicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100518000INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.2010-08-31DWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B09927000200PreviousHIBCC0
00192896010680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896010680001928960106801928960106800192896010680

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.25Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"

Contacts#

Phone, Email table
PhoneEmail
303-790-9411info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896044661BARR PROBE508-547508-5472018-09-14
00192896123397Smithwick Vasectomy Hook516-716516-7162026-05-12
00192896123373Skinner Tissue Forceps140-376H140-376H2026-05-11
00192896123380Biopsy Punch2901-117L2901-117L2026-05-11
00192896123403Mictec High Frequency Cable26944-3226944-322026-05-11
00192896123410Biopsy Cup2901-125L2901-125L2026-05-11
00192896112193HU Capsular Polisher12-268512-26852022-02-03
00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
00192896100671TEALES GORGET SPECULUM516-506516-5062025-02-24
00192896118003Reynolds Tenotomy Scissors2405-329B2405-329B2024-06-21
00192896115750Teales Gorget SpeculumT516-507T516-5072023-11-03
00192896099753LUXATOR ELEVATOR1100-586S11100-586S12018-09-21
00192896015272ENUCLEATION SCISSORS13-980513-98052018-09-13
00192896015289ENUCLEATION SCISSORS13-981013-98102018-09-13
00192896015296ENUCLEATION SCISSORS13-982013-98202018-09-13
00192896017214CASTROVIEJO LIP GRAFT CLAMP FORCEPS14-972514-97252018-09-17
00192896081635LUXATOR ELEVATOR1100-586C11100-586C12018-09-21
00192896081642LUXATOR ELEVATOR1100-586C21100-586C22018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896123359Sarns Myocardial DilatorSONTEC INSTRUMENTS, INC.DWP2026-04-23
00846159035926SCANLAN® ForcepsSCANLAN INTERNATIONAL INCDWP2025-11-13
14026704927873PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927880PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927897PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927903PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
00887482160893Symmetry GarrettASPEN SURGICAL PRODUCTS, INC.DWP2024-08-14
04058749118780NAFehling Instruments GmbH & Co. KGDWP2024-01-08
04058749118797NAFehling Instruments GmbH & Co. KGDWP2024-01-08
07070554104670Medistim Interconnect CableMedistim ASADWP2020-10-30
07070554104700Medistim Interconnect cableMedistim ASADWP2020-10-30
07070554104717Medistim Interconnect cableMedistim ASADWP2020-10-30
07070554104793Medistim Interconnect CableMedistim ASADWP2020-10-30
34026704652618PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652625PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652632PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652649PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652656PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652670PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652687PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704655961PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652663PILLINGTELEFLEX INCORPORATEDDWP2020-03-23
00192896010703GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-29
00192896005563GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010697GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010710TUNNELERSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010727TUBBS MITRAL VALVE DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896005570GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-21
00192896005587GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-21
00192896005594GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-21