Ivory

Basic Information

• Brand Name: Ivory
• Primary DI: J014660760871
• Version / Model: 66076087
• Catalog Number: 66076087
• Company Name: Kulzer GmbH
• Labeler DUNS: 315666321
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-07-04
• Public Version: 3
• Public Version Date: 2024-10-30
• Public Version Status: Update
• Public Device Record Key: cc5d7e29-ee95-416f-8441-4361d73e9558
• Distribution End Date: 2023-07-01

Device Description

Linguguard 5ct sample

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMA	DEPRESSOR, TONGUE, NON-SURGICAL	General Hospital	880.6230	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14066	Tongue depressor, surgical	A hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J014660760871	HIBCC
Unit of Use	J014660760870	HIBCC

Customer Contacts

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