AccessGUDID - DEVICE: Bel-Halo Dental Light (04952195406784)

GUDID

Device Identifier (DI) Information

Brand Name: Bel-Halo Dental Light
Version or Model: AL-D249W-XN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AL-D249W-XN
Company Name: TAKARA BELMONT CORP.

Primary DI Number: 04952195406784
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690540349 *Terms of Use

Device Description: Bel-Halo Dental Light UNIT MOUNT TYPE

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?
12351	Reflective dental room light	A mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light typically into or around the oral cavity of a patient to illuminate the site of a dental examination or procedure. It is constructed as a curved reflector with a dedicated central light bulb that produces and focuses the light, an outer housing with handles for dental staff to hold when manoeuvring the light head, and a jointed support arm. This device may be incorporated into a dental delivery system or be fixed separately to the ceiling or other support.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAZ	Light, Operating, Dental

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f6d620f-268b-4429-ab40-0428a85c7dcc
Public Version Date: August 02, 2023
Public Version Number: 2
DI Record Publish Date: June 16, 2023