AccessGUDID - DEVICE: Maquet Rolite (03700712412029)

GUDID

Device Identifier (DI) Information

Brand Name: Maquet Rolite
Version or Model: ARDPWT309006A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MAQUET SAS

Primary DI Number: 03700712412029
Issuing Agency: GS1
Commercial Distribution End Date: November 07, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 264700139 *Terms of Use

Device Description: ROL PWDII70SF AIM CL K3

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
FSS	Light, surgical, floor standing

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 20 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Humidity: between 20 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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: 1883eaf8-6759-42c1-b1bc-84b9c1c7efcf
Public Version Date: November 15, 2024
Public Version Number: 1
DI Record Publish Date: November 07, 2024