AccessGUDID - DEVICE: ASM SRC CS-20-1 UNIFORM PHANTOM (04056869002521)

GUDID

Device Identifier (DI) Information

Brand Name: ASM SRC CS-20-1 UNIFORM PHANTOM
Version or Model: 10223330
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3560012-00
Company Name: SIEMENS MEDICAL SOLUTIONS USA, INC.

Primary DI Number: 04056869002521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111494907 *Terms of Use

Device Description: No description.

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?
40630	Nuclear medicine phantom, test object	A device that includes a wide variety of two or three-dimensional (3-D) phantoms used in both calibration protocols and in subjective and quantitative evaluations of the performance of diagnostic nuclear medicine (NM) detector systems, e.g., gamma cameras, single photon emission computed tomography (SPECT), positron emission tomography (PET) or associated image display system and software programs. It consists of either fixed or variable configurations or patterns of absorbing or attenuating materials and radioactive source holders. The design can incorporate radioactive sealed sources or refillable radioactive source wells to which radioactivity can be added.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYQ	Phantom, flood source, nuclear

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
Special Storage Condition, Specify: Radioactive sources should be stored in a designated area which is secure & provides adequate shielding.Records which conform to local regulatory requirements are required for all radioactive sources.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5bcaba3c-7488-48b4-9e62-e29f2ddee1a2
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2018