AccessGUDID - DEVICE: Midmark (00841709107801)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark
Version or Model: TRML
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TRML
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709107801
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: The Track Mounted Dental Halogen Light is intended to be used as a component in a dental environment to provide lighting during dental procedures.

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):	No
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
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between -5 and 38 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -5 and 38 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e9ff255e-3c11-4027-9006-83bd7632c5b3
Public Version Date: January 08, 2021
Public Version Number: 2
DI Record Publish Date: May 31, 2018