AccessGUDID - DEVICE: PA 36 MR coil set 1.5T 098 (04056869014715)

GUDID

Device Identifier (DI) Information

Brand Name: PA 36 MR coil set 1.5T 098
Version or Model: 10185542
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Siemens Healthcare GmbH

Primary DI Number: 04056869014715
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313217003 *Terms of Use

Device Description: Contains Medical Device Mat. 10496542 (GTIN:04056869014906)

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):	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?
58250	PET/MRI system	A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination; their images may be transferred to other systems for additional processing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOS	Coil, magnetic resonance, specialty
LNI	System, nuclear magnetic resonance spectroscopic
LNH	System, nuclear magnetic resonance imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151579	000
K153343	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: dba7ac5b-284b-463c-a9b8-25f76fc3a1a4
Public Version Date: November 17, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016