FDA.reportPublic FDA data

GROOVED DIRECTOR TONGUE TIE

Primary DI
00192896024496
Brand
GROOVED DIRECTOR TONGUE TIE
Company
SONTEC INSTRUMENTS, INC.
Model
197-702
Catalog number
197-702
Device description
GROOVED DIRECTOR TONGUE TIE WITH PROBE POINT
Published
2018-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGMProbe And Director, Gastro-Urology
HXPINSTRUMENT, BENDING OR CONTOURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896024496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896024496001928960244961928960244960192896024496

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological probeA slender, rod-like, hand-held manual surgical instrument, typically made of flexible metal with a blunt bulbous tip, designed for exploring gastroenterological/urological (GU) structures during a GU procedure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.5Inch

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(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
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
00840311262960Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HXP2026-04-27
00190776416201MillenniumAvalign Technologies, Inc.FGM2026-02-12
00192896122543Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00192896122550Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00199150029464Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-10-19
10886982335784NASynthes GmbHHXP2024-10-09
10886982335913NASynthes GmbHHXP2024-10-09
10886982336293NASynthes GmbHHXP2024-10-09
10886982336309NASynthes GmbHHXP2024-10-09
00192896116252Probe With EyeSONTEC INSTRUMENTS, INC.FGM2024-01-09
07640187461572Bending IronBonebridge AGHXP2022-12-23
07898506814527QuinelatoSchobell Industrial LtdaFGM2022-12-20
07898506814534QuinelatoSchobell Industrial LtdaFGM2022-12-20
07898506814541QuinelatoSchobell Industrial LtdaFGM2022-12-20
07898506814558QuinelatoSchobell Industrial LtdaFGM2022-12-20
07898506814565QuinelatoSchobell Industrial LtdaFGM2022-12-20
07898506814572QuinelatoSchobell Industrial LtdaFGM2022-12-20
07898506814633QuinelatoSchobell Industrial LtdaFGM2022-12-20
14026704799302PILLINGTELEFLEX INCORPORATEDHXP2022-12-08
14026704799333PILLINGTELEFLEX INCORPORATEDHXP2022-12-08
00643169047907Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2022-11-26
00763000522926Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2022-10-13
10888439920697CARDINAL HEALTHCardinal Health 200, LLCFGM2021-03-02
10886982191809NASynthes GmbHHXP2019-12-28
10886982269881NASynthes GmbHHXP2019-03-04
10886982269898NASynthes GmbHHXP2019-03-04
00192896070158MAGNETIC PROBESONTEC INSTRUMENTS, INC.FGM2018-09-07
00192896070189BALL POINT PROBESONTEC INSTRUMENTS, INC.FGM2018-09-07
10887587039206NASynthes GmbHHXP2018-08-29
10887587039213NASynthes GmbHHXP2018-08-29