AccessGUDID - DEVICE: Captus 4000e Thyroid Uptake System with 2 in well (00859942006423)

GUDID

Device Identifier (DI) Information

Brand Name: Captus 4000e Thyroid Uptake System with 2 in well
Version or Model: 5430-30154
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5430-30154
Company Name: Mirion Technologies (capintec), Inc.

Primary DI Number: 00859942006423
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047684501 *Terms of Use

Device Description: The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.

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):	Yes
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?
40648	Thyroid-uptake nuclear medicine system	An assembly of diagnostic devices that comprise a non-imaging nuclear medicine system designed primarily for radioactive iodine related thyroid uptake measurement and analysis applications. It can typically be upgraded with the addition of software and hardware for use in various quality assurance (QA) or radioimmunoassay laboratory applications, e.g., wipe-test assessment or Schilling tests. It typically includes a multichannel analyser, computer, scintillation detector, detector support equipment, an operator's console, video display, well counter detector, collimator, shielding, and application software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZD	Probe, Uptake, 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: 3b7269e5-3e02-4e1c-8cca-f6330b490d6c
Public Version Date: December 14, 2022
Public Version Number: 2
DI Record Publish Date: July 11, 2022