AccessGUDID - DEVICE: SPECTRA EXAMINATION LIGHT SERIES (10841736112035)

GUDID

Device Identifier (DI) Information

Brand Name: SPECTRA EXAMINATION LIGHT SERIES
Version or Model: AUT1W
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SKYTRON LLC

Primary DI Number: 10841736112035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078375583 *Terms of Use

Device Description: LED Examination Light; Ceiling, Wall, Stand, or Boom options

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?
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
KZF	Device, Medical Examination, Ac Powered

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
Special Storage Condition, Specify: NO CONDENSATION
Storage Environment Atmospheric Pressure: between 17 and 34 Inches of Mercury
Storage Environment Humidity: between 13 and 88 Percent (%) Relative Humidity
Storage Environment Temperature: between 17 and 143 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c30023b9-7948-4b96-9a37-5998b682a7d8
Public Version Date: January 08, 2021
Public Version Number: 2
DI Record Publish Date: January 01, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-759-8766
Email: info@skytron.us

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