Symmetry Olsen

Basic Information

• Brand Name: Symmetry Olsen
• Primary DI: 00841785107702
• Version / Model: 607000
• Catalog Number: 607000
• Company Name: OLSEN MEDICAL, LLC
• Labeler DUNS: 079344210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 5
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: e4e9fe38-e8cd-4a59-9805-88617f3eafd6

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36309	Laser beam eye protector, patient	A protective device that is designed to be placed either under or over the patient's eyelids in order to protect the eyes from injury during laser surgery.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30841785107703	GS1		12	In Commercial Distribution
Primary	00841785107702	GS1

Premarket Submissions

Submission Number	Supplement Number
K852404	000