BISHOP-HARMON IRRIGATION BULB & ADAPTER

Basic Information

• Brand Name: BISHOP-HARMON IRRIGATION BULB & ADAPTER
• Primary DI: 00192896074996
• Version / Model: 16-5340
• Catalog Number: 16-5340
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-20
• Public Version: 1
• Public Version Date: 2018-10-22
• Public Version Status: New
• Public Device Record Key: eea76ad5-ac25-464a-b8a0-8537fa791637

Device Description

BISHOP-HARMON IRRIGATION BULB & ADAPTER

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: No
• 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
HMX	Cannula, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46909	Ophthalmic working-channel cannula, reusable	A rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896074996	GS1

Customer Contacts

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