Single-use lenses for RESIGHT, WIDE-ANGLE LENS

Basic Information

• Brand Name: Single-use lenses for RESIGHT, WIDE-ANGLE LENS
• Primary DI: 04049539106735
• Version / Model: 302721-9097-000
• Company Name: Carl Zeiss Meditec AG
• Labeler DUNS: 342228620
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-07
• Public Version: 1
• Public Version Date: 2024-11-15
• Public Version Status: New
• Public Device Record Key: 49255395-18aa-470d-9599-797484fb4da4

Device Description

Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewing system. The fundus viewing system is an accessory for surgical microscopes which is used for surgery on the posterior segment of the eye. It is used for stereoscopic imaging of the posterior segment and the retina.

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: 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
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	878.4700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67065	Ophthalmic surgical microscope lens	A lens intended to be used with an ophthalmic surgical microscope to facilitate stereoscopic imaging during posterior segment surgery. The lens is typically attached to the parent device such that it enters the surgical field, however is not intended for patient contact. It may be available in a variety of sizes and optical powers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049539106735	GS1
Package	04049539106742	GS1	dispenser	12	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Width	19	Millimeter
Height	27	Millimeter
Length	38	Millimeter

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.