AccessGUDID - DEVICE: MRI Stretcher with Fowler Positioning (00879942070767)

GUDID

Device Identifier (DI) Information

Brand Name: MRI Stretcher with Fowler Positioning
Version or Model: 240-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 240-110
Company Name: Mirion Technologies (capintec), Inc.

Primary DI Number: 00879942070767
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047684501 *Terms of Use

Device Description: The MRI Stretcher with Fowler positioning is non-magnetic, all aluminum, and designed for heavy-duty use.

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?
36937	MRI system table, non-powered	A non-powered mobile table that is made of ferromagnetically inactive materials (non-magnetic) to render it compatible with magnetic resonance imaging (MRI) environment, and that is designed for the transport of the patient to and from the examination table in the MRI system. This table can be safely left in the MRI examination room because of its compatibility, whilst the patient is being examined.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPO	Stretcher, Wheeled

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 15b2c8f9-34f9-4793-b064-b6ce5b2b3290
Public Version Date: August 08, 2023
Public Version Number: 1
DI Record Publish Date: July 31, 2023