AccessGUDID - DEVICE: mMR Body coil set (04056869015156)

GUDID

Device Identifier (DI) Information

Brand Name: mMR Body coil set
Version or Model: 10606589
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Siemens Healthcare GmbH

Primary DI Number: 04056869015156
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. 10606492 (GTIN:04056869015132)

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
OUO	Tomographic imager combining emission computed tomography with nuclear magnetic resonance

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133226	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: efcf4b0f-cfee-4a2c-aea5-dd4b527a772d
Public Version Date: November 17, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016

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)888-7436
Email: CONTACT@SIEMENS-HEALTHINEERS.COM

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