AccessGUDID - DEVICE: Celestial Star (00853538008105)

GUDID

Device Identifier (DI) Information

Brand Name: Celestial Star
Version or Model: CS2050M-MRI-UK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS2050M-MRI-UK
Company Name: Sunnex

Primary DI Number: 00853538008105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073797367 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
36843	Mobile examination/treatment room light	A mobile 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), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another.	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
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c9d36907-0426-4ed7-8a47-32e7015f8e82
Public Version Date: January 08, 2021
Public Version Number: 3
DI Record Publish Date: February 26, 2018

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)445-7869
Email: bill.long@sunnex.com

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