S4 OPTIK

Basic Information

• Brand Name: S4 OPTIK
• Primary DI: 08056098470517
• Version / Model: TONOMETER A900
• Catalog Number: 102002200.S
• Company Name: COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
• Labeler DUNS: 432448470
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-14
• Public Version: 1
• Public Version Date: 2020-12-22
• Public Version Status: New
• Public Device Record Key: 5c8b04b9-4f06-4094-b252-434779974fa5

Device Description

APPLANATION TONOMETER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
HKY	Tonometer, Manual	Ophthalmic	886.1930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32721	Ophthalmic tonometer, manual	An ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056098470517	GS1

Premarket Submissions

Submission Number	Supplement Number
K022054	000