Ocu-Film +

Basic Information

• Brand Name: Ocu-Film +
• Primary DI: 00812559010115
• Version / Model: 230651
• Company Name: REICHERT, INC.
• Labeler DUNS: 126650253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7219b8e8-dbcc-454d-8d69-656baa1fb4a2

Device Description

Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps protect patients from risk of cross-contamination.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKY	Tonometer, Manual	Ophthalmic	886.1930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45750	Ophthalmic tonometer tip cover	A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812559010115	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070534	000