ZEISS Optical Inserts

Basic Information

• Brand Name: ZEISS Optical Inserts
• Primary DI: 04064495039415
• Version / Model: 39000032753
• Catalog Number: 39000032753
• Company Name: Carl Zeiss Vision International GmbH
• Labeler DUNS: 344934760
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-12-20
• Public Version: 1
• Public Version Date: 2023-12-28
• Public Version Status: New
• Public Device Record Key: db98dbef-e761-4ced-beb7-3ebdbe1aa0f2

Device Description

ZEISS Optical Inserts

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
HQG	Lens, spectacle, non-custom (prescription)	Ophthalmic	886.5844	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35957	Prescription spectacle lens, custom-made	An ophthalmic lens made of glass or plastic that is manufactured in accordance with a specific patient prescription (custom-made) and intended to be worn in front of the eyes to correct the refractive errors of that patient's eyesight, e.g., refractive ametropia (myopia, hyperopia and astigmatism), and possibly to protect the eyes against radiation or mechanical hazards; it has no additional specialized features. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00000000000000	GS1
Primary	04064495039415	GS1

Customer Contacts

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