Gonio Ready 200 for f=200mm

Basic Information

• Brand Name: Gonio Ready 200 for f=200mm
• Primary DI: 00852475007332
• Version / Model: 53671
• Catalog Number: 53671
• Company Name: OCULUS SURGICAL INC
• Labeler DUNS: 015409582
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-07
• Public Version: 4
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 7027f553-3cdf-4a9b-9ef5-3456247212fb

Device Description

1 Each 53671 Gonio Ready 200 for f=200mm

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKS	Prism, Gonioscopic	Ophthalmic	886.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47946	Ophthalmic diagnostic condensing lens	An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852475007332	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius