BK X/O (according to Kochniss), without convex cylinders, coated, inclusive tria

Basic Information

• Brand Name: BK X/O (according to Kochniss), without convex cylinders, coated, inclusive tria
• Primary DI: 04049584001030
• Version / Model: 33101
• Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 317138956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 79c319d6-c223-4646-b119-de1c2cac32bc

Device Description

BK X/O (according to Kochniss), without convex cylinders, coated, inclusive trial lens case

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: No
• PM Exempt: Yes
• 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
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	886.1405	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32791	Trial lens frame	A device used in ophthalmic work for placing, holding, and exchanging trial lenses in front of the eyes of the patient during a sight-testing procedure.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049584001030	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal