FDA.reportPublic FDA data

Teales Gorget Speculum

Primary DI
00192896115750
Brand
Teales Gorget Speculum
Company
SONTEC INSTRUMENTS, INC.
Model
T516-507
Catalog number
T516-507
Device description
Teales Gorget Speculum Tapered Half-Moon Probe End Angled Flat Handle Titanium
Published
2023-11-03
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
FXESPECULUM, NON-ILLUMINATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXESpeculum, Non-IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896115750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896115750001928961157501928961157500192896115750

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, reusableA collection of various surgical instruments, dressings, pharmaceuticals and the necessary materials intended to be used to perform a urological surgical procedure; it is not dedicated to a specific type of urological surgical procedure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Shaft Length4.75Inch

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
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
00192896097056Laparoscopic Bulldog Clamp2901-281-252901-281-252019-05-09
00192896097063Laparoscopic Bulldog Clamp2901-281-402901-281-402019-05-09
00192896123793Adson Tissue Forceps140-302DLQ140-302DLQ2026-10-06
00192896123809Micro Skinner Forceps140-519M140-519M2026-10-06
00192896123816Jacobson Needle Holder2300-142D2300-142D2026-10-06
00192896123823Thumb Dressing Forceps136-610Q136-610Q2026-10-06
00192896123830Thumb Dressing Forceps136-615Q136-615Q2026-10-06
00192896123847Thumb Dressing Forceps136-619Q136-619Q2026-10-06
00192896123854Gum Scissors475-153Q475-153Q2026-10-06
00192896111394Laparoscopic Bulldog Clamp2901-281-60T2901-281-60T2021-10-22
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411565MillenniumAvalign Technologies, Inc.FXE2026-08-07
00850088713213PRINCETONPrinceton Medical Group, Inc.FXE2026-07-23
00190776395490MillenniumAvalign Technologies, Inc.FXE2026-07-14
00810158218888PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218895PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218901PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218178PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00810158218185PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00810158218192PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00194613065607MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613104726MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613120290MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00810158214699PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00810158214705PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00192896100671TEALES GORGET SPECULUMSONTEC INSTRUMENTS, INC.FXE2025-02-24
00190776390167MillenniumAvalign Technologies, Inc.FXE2024-05-31
G586N6867570Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867580Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867590Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867610Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
00190776041786AvalignAvalign Technologies, Inc.FXE2023-11-13
00190776316471MILLENNIUMAvalign Technologies, Inc.FXE2023-09-28
G453333611190PEAK MEDICALPeak Medical Distribution Inc.FXE2023-09-12
G4533336204900PEAK MEDICALPeak Medical Distribution Inc.FXE2023-09-12
00842962137956HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137963HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137970HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962119150HNM MEDICALHNM STAINLESS, LLC.FXE2023-03-30
14026704792211PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
14026704792228PILLINGTELEFLEX INCORPORATEDFXE2022-12-08