Ophthalmic unit

Basic Information

• Brand Name: Ophthalmic unit
• Primary DI: 06971821406040
• Version / Model: TCS-820
• Company Name: Ningbo Ming Sing Optical R & D Co., Ltd.
• Labeler DUNS: 654386890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 1
• Public Version Date: 2020-09-08
• Public Version Status: New
• Public Device Record Key: c49dde17-2759-44a7-ae6a-f23d6ffe2d95

Device Description

Mini design, take up less space.Rotatory tray for refractometer and other devices.Electric lifting for table and Phoropter arm.Phoropter arm can be rotated 90° to avoid interference with the auto refractometer.

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: Yes
• 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: No
• 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
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	886.4855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46433	Ophthalmic instrument table, manual	A device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It may have manual height adjustments enabling the clinician to raise/lower the surface to align the instruments to the patient's eye level.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971821406040	GS1

Customer Contacts

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