Stephens Instruments

Basic Information

• Brand Name: Stephens Instruments
• Primary DI: 00810799031471
• Version / Model: S2-1178
• Catalog Number: S2-1178
• 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: 43ec3160-c2f1-485c-9284-c8cabb9a657b

Device Description

Chuck and Burr, For Pterygium Brush, 2.5mm Round Tip, Fine Grit, Diamond Dusted

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
HOF	Burr, corneal, manual	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46394	Corneal bur, abrasion	A small shaft made of a hard metal (e.g., steel) with a diamond sphere at its tip that is designed for abrasion of the cornea to polish corneal scratches and/or the pterygium bed after surgical removal, and/or for abrasion of lid margin lesions. It is attached to the tip of a special slow-rotation ophthalmic handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810799031471	GS1

Customer Contacts

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

Storage Conditions

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