AccessGUDID - DEVICE: Z PET Syringe Shield, 5cc (00859942006973)

GUDID

Device Identifier (DI) Information

Brand Name: Z PET Syringe Shield, 5cc
Version or Model: 007-945
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 007-945
Company Name: Mirion Technologies (capintec), Inc.

Primary DI Number: 00859942006973
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047684501 *Terms of Use

Device Description: Tungsten Syringe Shield for PET

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?
38379	Syringe radiation shield	A radiation protective device made to surround a syringe while radioactive material is drawn up into the syringe and during patient injection. It is intended to shield the user from unnecessary exposure to radiopharmaceuticals or other radioactive material used in diagnostic or therapeutic procedures. It is typically made of lead (Pb), lead with a leaded glass insert, or clear lead-equivalent plastic materials.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWR	Holder, Syringe, Lead

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: c4385b0a-6112-494d-b8b5-524166c1f210
Public Version Date: December 14, 2022
Public Version Number: 2
DI Record Publish Date: July 11, 2022