AccessGUDID - DEVICE: Eckert & Ziegler Isotope Products, Inc. (00810117210182)

GUDID

Device Identifier (DI) Information

Brand Name: Eckert & Ziegler Isotope Products, Inc.
Version or Model: A3418-221
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Eckert & Ziegler Isotope Products, Inc.

Primary DI Number: 00810117210182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041668633 *Terms of Use

Device Description: Quality Assurance Line Source

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?
40608	Nuclear medicine phantom, line source	A device which is either a linear radioactive sealed source or refillable linear radiolucent tube to which radioactivity can be added. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of photon detector systems used in nuclear medicine imaging applications and associated image acquisition, display and analysis computer programs.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXD	Source, Calibration, Sealed, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa25f095-e726-47fa-a3cc-35e21d92984b
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022