FMAT1 Prism B

Basic Information

• Brand Name: FMAT1 Prism B
• Primary DI: 00867009000215
• Version / Model: Prism B
• Company Name: FALCK MEDICAL INC
• Labeler DUNS: 010283033
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a928615e-55c4-4146-9cab-e1fc95a18d80

Device Description

Disposable single use prism for FMAT1 Device

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

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	00867009000215	GS1
Package	10867009000212	GS1	Inner Pack	250	In Commercial Distribution
Package	20867009000219	GS1	Case	5	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Length	35	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 35 Degrees Celsius