FDA.reportPublic FDA data

GROOVED DIRECTOR

Primary DI
00192896076686
Brand
GROOVED DIRECTOR
Company
SONTEC INSTRUMENTS, INC.
Model
197-700
Catalog number
197-700
Device description
GROOVED DIRECTOR TONGUE TIE PROBE TIP STAINLESS STEEL
Published
2018-09-20
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
00192896076686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896076686001928960766861928960766860192896076686

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
Length4.5Inch

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
00192896103603ROCHESTER CARMALT FORCEPS1100-151Q1100-151Q2020-07-23
00192896038110SONTEC-MICHELE TREPHINE419-392419-3922018-09-11
00192896038127SONTEC-MICHELE TREPHINE419-393419-3932018-09-11
00192896038134SONTEC-MICHELE TREPHINE419-394419-3942018-09-11
00192896038141SONTEC-MICHELE TREPHINE419-395419-3952018-09-11
00192896038158SONTEC-MICHELE TREPHINE419-396419-3962018-09-11
00192896038165SONTEC-MICHELE TREPHINE419-397419-3972018-09-11
00192896038172SONTEC-MICHELE TREPHINE419-398419-3982018-09-11
00192896094710INGE LAMINA SPREADER RETRACTOR417-056417-0562019-03-07
00192896123427Trocar20910-1120910-112026-06-02
00192896123434Flexible Trocar Sleeve15-16141-0315-16141-032026-06-02
00192896123441Barraquer Anis Needle Holder15-3810Q15-3810Q2026-06-02
00192896105553Rochester Carmalt Forceps1100-1541100-1542020-11-16
00192896105591Bone Tamp335-400335-4002020-11-18
00192896105607Bone Tamp335-404335-4042020-11-18
00192896102637Carmalt Forceps1100-152L1100-152L2020-06-15
00192896101524BONE TAMP1103-197A1103-197A2020-05-11
00192896099715WILDE ETHMOID RONGEUR468-622468-6222018-09-20
00192896094109ROCHESTER CARMALT FORCEPS1100-153Q1100-153Q2019-03-07
00192896094475ROCHESTER CARMALT FORCEPS1100-152Q1100-152Q2019-03-07

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