BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

FIBEROPTIC HEADLUX

DI: B366HDL200 · Model: R00 · Ecleris

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: FIBEROPTIC HEADLUX
Primary DI: B366HDL200
Version / Model: R00
Catalog Number: HDL200
Company Name: Ecleris
Labeler DUNS: 043555079
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-06-10
Public Version: 1
Public Version Date: 2022-06-21
Public Version Status: New
Public Device Record Key: 3dc9990b-846a-4877-bc70-f8b478f7e9b1

Device Description

HEADLIGHT

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: Yes
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
FCT	Headlight, Fiberoptic Focusing	Ophthalmic	886.4335	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46807	Head-worn lamp	An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B366HDL200	HIBCC

Customer Contacts

Phone: 786-483-7490
Email: [email protected]

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 30 – 75 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal
Type: Storage Environment Temperature
Temperature Range: -40 – 55 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal