FDA.reportPublic FDA data

NITINOL MEMORY DILATOR

Primary DI
00192896005839
Brand
NITINOL MEMORY DILATOR
Company
SONTEC INSTRUMENTS, INC.
Model
2700-0331
Catalog number
2700-0331
Device description
NITINOL MEMORY DILATOR
Published
2018-08-15
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896005839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896005839001928960058391928960058390192896005839

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
Device Size Text, specify0
Length5.5Inch

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896012639ALGERBRUSH DIAMOND BURR11-461011-46102018-09-18
00192896012646ALGERBRUSH DIAMOND FINE GRIT BURR11-461111-46112018-09-18
00192896012653ALGERBRUSH DIAMOND BURR11-461211-46122018-09-18
00192896012660ALGERBRUSH DIAMOND BURR11-461311-46132018-09-18
00192896012677ALGERBRUSH DIAMOND BURR11-461411-46142018-09-18
00192896072398ALGERBRUSH DIAMOND BURR11-460911-46092018-09-19
00192896092792UNIVERSITY OF MINNESOTA CHEEK RETRACTOR207-210207-2102019-01-03
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

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
00192896010680GARRETT 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