AccessGUDID - DEVICE: Capintec T-Vial Shield (00859942006263)

GUDID

Device Identifier (DI) Information

Brand Name: Capintec T-Vial Shield
Version or Model: T-Vial Shield
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0665-0002
Company Name: Mirion Technologies (capintec), Inc.

Primary DI Number: 00859942006263
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 047684501 *Terms of Use

Device Description: T-Vial Shield

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?
38380	Vial radiation shield	A device, sometimes called a vial holder, designed to partially or completely surround a vial or a container of a solid or liquid radioactive material. It protects persons from unnecessary radiation exposure by partially or totally blocking the radiation emissions from a vial or similar container holding a radiopharmaceutical or other radioactive material used in diagnostic or therapeutic procedures. It is made of lead (Pb) or lead-equivalent materials, the shielding properties may vary depending on the isotopes they are intended to be used with. Some include an opening that allows needle access to the vial contents and some are either totally transparent or include a window.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWW	Shield, Vial

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: 39d8d0b6-835f-4743-baec-1bd17b5035ae
Public Version Date: April 08, 2024
Public Version Number: 3
DI Record Publish Date: November 28, 2018