Teales Gorget Speculum

Basic Information

• Brand Name: Teales Gorget Speculum
• Primary DI: 00192896115750
• Version / Model: T516-507
• Catalog Number: T516-507
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-03
• Public Version: 1
• Public Version Date: 2023-11-13
• Public Version Status: New
• Public Device Record Key: b20d0fa9-d01a-4980-bcb5-211aef2d7525

Device Description

Teales Lithotomy Gorget Speculum Tapered Half Moon Shaped Probe Ended Blade Angled Flat Handle Titanium

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FXE	SPECULUM, NON-ILLUMINATED	General, Plastic Surgery	878.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46415	Urological surgical procedure kit, medicated, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896115750	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Shaft Length	4.75	Inch
Device Size Text, specify			Handle Length 4 Inches