Stephens Instruments

Basic Information

• Brand Name: Stephens Instruments
• Primary DI: 00810799038081
• Version / Model: SC-1015
• Catalog Number: SC-1015
• Company Name: KRISHNA IMPORTS INC
• Labeler DUNS: 081853285
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 1
• Public Version Date: 2020-09-30
• Public Version Status: New
• Public Device Record Key: 8f633016-ea64-4180-9c04-879ca80f215b

Device Description

Bulb Adaptor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMX	Cannula, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48013	Ophthalmic surgical instrument handle quick lock adaptor	A connecting device designed to allow the attachment of an ophthalmic surgical instrument tip to an ophthalmic surgical instrument handle. It is typically in the form of a small, stainless steel, circular adaptor with a threaded interface that attaches to a threaded portion of the handle and provides a quick lock mechanism (e.g., bayonet fitting) that secures/releases the inserted tip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810799038081	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature