AccessGUDID - DEVICE: ROLITE VOLISTA STANDOP (03700712400859)

GUDID

Device Identifier (DI) Information

Brand Name: ROLITE VOLISTA STANDOP
Version or Model: ARDROL309020A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MAQUET SAS

Primary DI Number: 03700712400859
Issuing Agency: GS1
Commercial Distribution End Date: August 06, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 264700139 *Terms of Use

Device Description: VST40 TK AIM ROL

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?
42513	Transportable medical equipment stand, non-powered	A non-powered (non-active) transportable device [e.g., on wheels or easily movable] designed to support medical equipment (e.g., monitors, pumps, consoles) used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSY	Light, surgical, ceiling mounted
FTD	Lamp, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130513	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 43cbbdb6-07a1-4c81-9e0d-aca0a1e06269
Public Version Date: December 11, 2024
Public Version Number: 8
DI Record Publish Date: September 16, 2016