Chromophare

Basic Information

• Brand Name: Chromophare
• Primary DI: 07613327296167
• Version / Model: CH00000001
• Catalog Number: CH00000001
• Company Name: Berchtold Holding GmbH
• Labeler DUNS: 316153824
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: 244b08e6-4062-481b-ac5f-708900df371d

Device Description

Berchtold Surgical Light System ? Ceiling Mounted

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
KZF	DEVICE, MEDICAL EXAMINATION, AC POWERED	General Hospital	880.6320	1
FSY	Light, surgical, ceiling mounted	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12276	Fixed examination/treatment room light	A fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.	No	Active
37332	Operating room light system	An assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327296167	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal