TID - Todorich Illuminated Depressor

Basic Information

• Brand Name: TID - Todorich Illuminated Depressor
• Primary DI: B384VS080016
• Version / Model: VS0800
• Catalog Number: VS0800
• Company Name: Vortex Surgical, Inc.
• Labeler DUNS: 080375891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-26
• Public Version: 2
• Public Version Date: 2022-11-21
• Public Version Status: Update
• Public Device Record Key: f5b2e8c5-6693-43f1-870b-e867cc8fea40

Device Description

Illuminated Depressor Cap for light pipes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNX	Depressor, Orbital	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64259	Ophthalmic fibreoptic light instrument orbital-depression tip	A small transparent device intended to be placed over the traumatic tip of an ophthalmic fibreoptic light instrument to allow the instrument to be used as an illuminating orbital depressor for: 1) extra-orbital displacement of the sclera; and 2) transscleral illumination, to facilitate examination during posterior segment surgery. It is a small cap-like device made from synthetic polymer materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B384VS080016	HIBCC

Customer Contacts

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