FDA.reportPublic FDA data

Grooved Director

Primary DI
00192896115217
Brand
Grooved Director
Company
SONTEC INSTRUMENTS, INC.
Model
197-695
Catalog number
197-695
Device description
Grooved Director With Tongue Tie Stainless Steel
Published
2023-08-07
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896115217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896115217001928961152171928961152170192896115217

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological directorA slender, rod-like surgical instrument made of metal, typically with groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure. The distal shaft may be straight or curved and the proximal handle formed as a finger grip. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch

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

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896045736TURNER WARWICK UROLOGICAL RETRACTOR516-8042-SET516-8042-SET2018-09-17
00192896123946Micro Osteotome475-7864475-78642026-10-27
00192896123953Laparoscopic Bulldog Clamp2901-281-452901-281-452026-10-27
00192896123960Laparoscopic Bulldog Clamp2901-281-602901-281-602026-10-27
00192896123977Yankauer Pediatric Suction Tube180-446180-4462026-10-27
00192896123984Trepsat Flap Dissecting Forceps438-635G438-635G2026-10-27
00192896123991Trepsat Flap Dissecting Forceps438-636G438-636G2026-10-27
00192896124004Trepsat Flap Dissecting Forceps438-637G438-637G2026-10-27
00192896124011Debakey Beck Clamp2100-7872100-7872026-10-27
00192896124028Debakey Beck Clamp2100-7882100-7882026-10-27
00192896040885Antrum Grasping Forceps468-360468-3602018-09-10
00192896123861Sheen Mini Cartilage Cutting Block350-845M350-845M2026-10-14
00192896123878Allis Tissue Forceps140-331Q140-331Q2026-10-14
00192896123885Allis Tissue Forceps140-330AQ140-330AQ2026-10-14
00192896123892Ceramitec Debakey Forceps2200-168CL2200-168CL2026-10-14
00192896123908Debakey Forceps2200-168L2200-168L2026-10-14
00192896123915Ceramitec Debakey Forceps2200-172CL2200-172CL2026-10-14
00192896123922Knurled Nut2500-200-1B2500-200-1B2026-10-14
00192896123939Bishop Harmon Tissue Forceps14-380114-38012026-10-14
00192896097049Laparoscopic Bulldog Clamp Forceps2901-2812901-2812019-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435875MillenniumAvalign Technologies, Inc.FGM2026-09-30
00190776427825MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427832MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427849MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427856MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427863MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427870MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427887MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427894MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427900MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427917MillenniumAvalign Technologies, Inc.FGM2026-08-26
00192896122826Barr ProbeSONTEC INSTRUMENTS, INC.FGM2026-03-10
00190776416201MillenniumAvalign Technologies, Inc.FGM2026-02-12
00192896122543Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00192896122550Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00190776411831MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411848MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411855MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411862MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411879MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411886MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411893MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411909MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776406325MillenniumAvalign Technologies, Inc.FGM2025-07-21
G453332312160PEAK MEDICALPeak Medical Distribution Inc.FGM2025-06-17
00190776399993MillenniumAvalign Technologies, Inc.FGM2025-06-03
04049047024422GimmiGimmi GmbHFGM2025-05-06
G4533352001180PEAK MEDICALPeak Medical Distribution Inc.FGM2025-01-20
G586G91027310Novo SurgicalNOVO SURGICAL, INC.FGM2024-10-15
04049197272230RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20