AccessGUDID - DEVICE: Falck Medical Multi-Function Applanation Tonometer (00867009000208)

GUDID

Device Identifier (DI) Information

Brand Name: Falck Medical Multi-Function Applanation Tonometer
Version or Model: FMAT1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FALCK MEDICAL INC

Primary DI Number: 00867009000208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010283033 *Terms of Use

Device Description: Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodynamometry and Tonography Measurement

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35399	Ophthalmic tonometer, line-powered	An ophthalmic, line-powered, measuring instrument used for determining the intraocular pressure (IOP) by exerting an external force against 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). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKY	Tonometer, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 15 Centimeter
Length: 20 Centimeter
Depth: 5 Centimeter

Device Record Status

Public Device Record Key: ff71fa08-5a8a-45e7-b27f-eb4a46767852
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 08, 2016