VDC606

Basic Information

• Brand Name: VDC606
• Primary DI: 08719324589048
• Version / Model: 0202020117
• Company Name: Comecer Netherlands B.V.
• Labeler DUNS: 418153144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 046bb47b-33b0-4214-95db-2a802c86932a

Device Description

Dose Calibrator for the measuring of radiopharmaceutical activity in syringes and vials

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPT	Calibrator, dose, radionuclide	Radiology	892.1360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40738	Radioisotope calibration system	A system of radioactivity measuring instruments designed for quantifying the amount of radiation in a radiopharmaceutical dose or other test samples inserted into a shielded chamber or well for measurement. The system's instruments radiation level measurements in units of Curie and/or Becquerel are used to quantify the radioactivity in diagnostic or therapeutic radiopharmaceuticals prior to and after patient administration. This will be used to measure radiation levels of in vitro diagnostic test samples, e.g., those required for Schilling tests, Cr-51 or I-125 blood volume.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719324589048	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K030066	000