Haag Streit UK

Basic Information

• Brand Name: Haag Streit UK
• Primary DI: 05060179470559
• Version / Model: 5805100
• Catalog Number: 5805100
• Company Name: HAAG-STREIT UK LIMITED
• Labeler DUNS: 504108242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-07-22
• Public Version: 4
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: 7f47a1b7-0ff6-4f83-9021-1c3853a18b83

Device Description

TONOSAFE(EUROPE)100 PRISMS/BOX

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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: Yes
• 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
62405	Ophthalmic tonometer probe	A device intended to be attached to an ophthalmic tonometer and to make brief and gentle contact with the eye surface for the measurement of intraocular pressure (IOP). It may be in the form of a prism with a dedicated mount (mount may be included with the device) or a thin metal or plastic rod with a plastic distal tip designed to be moved towards the eye by the tonometer (e.g., via magnetization), which uses probe deceleration and rebound time measurements to calculate IOP. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060179470559	GS1
Unit of Use	05060179471181	GS1

Customer Contacts

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