AccessGUDID - DEVICE: CII Transporter II (00859942006294)

GUDID

Device Identifier (DI) Information

Brand Name: CII Transporter II
Version or Model: 0670-2026
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0670-2026
Company Name: Mirion Technologies (capintec), Inc.

Primary DI Number: 00859942006294
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: Shielded Syringe Carrier 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?
40903	Radiation shielding container, transport/transfer	A radiation protection device specifically designed to shield persons from harmful radiation exposure during air or land based shipping, transfer and delivery of radioactive materials (e.g., radioisotopes) from facility to facility. Designs typically incorporate a container with a lead lining sufficient to attenuate the emissions from the contained radioactive materials, sources, radiopharmaceuticals, or radiation containing devices being transported. This device is used for intra- and inter-hospital transportation of syringes, vials or other devices containing radioisotopes.	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: 447341f7-fd57-4c39-8b58-79612f7d6376
Public Version Date: April 08, 2024
Public Version Number: 3
DI Record Publish Date: July 01, 2019