AccessGUDID - DEVICE: MIRA Minor Surgery Light (00667774000195)

GUDID

Device Identifier (DI) Information

Brand Name: MIRA Minor Surgery Light
Version or Model: MIRA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L-MLED90-CM-SC-EX
Company Name: Amico Lights Corporation

Primary DI Number: 00667774000195
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203021407 *Terms of Use

Device Description: Mira LED 90, Ceiling Mount, Single, Extended Arm

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:	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSY	Light, Surgical, Ceiling Mounted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131893	000

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
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 03495521-50f8-4873-83c3-7ea2761498f3
Public Version Date: January 08, 2021
Public Version Number: 4
DI Record Publish Date: August 09, 2017