Stephens Instruments

Basic Information

• Brand Name: Stephens Instruments
• Primary DI: 00810799039996
• Version / Model: SSD9 1601
• Catalog Number: SSD9 1601
• Company Name: KRISHNA IMPORTS INC
• Labeler DUNS: 081853285
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: 9edb216f-213b-4ec3-9142-cd824f41c6c3

Device Description

Berkeley Double Marker 3.0mm & 3.5mm, Single use, 10/Box

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMQ	Marker, sclera	Ophthalmic	886.4570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12442	Corneal marker, single-use	A manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810799039989	GS1	box	10	In Commercial Distribution
Primary	00810799039996	GS1

Customer Contacts

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

Storage Conditions

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